Trial Outcomes & Findings for A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma (NCT NCT01320085)
NCT ID: NCT01320085
Last Updated: 2024-01-24
Results Overview
Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.0, was defined as participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause, whichever occurred first (maximum duration of up to 33 months)
Results posted on
2024-01-24
Participant Flow
This study included only those participants for whom the presence of a v-raf murine sarcoma viral oncogene homolog B1 (BRAFV600) or Neuroblastoma RAS viral oncogene homolog (NRAS) gene mutation in the tumor tissue was determined.
Participant milestones
| Measure |
Binimetinib 45 mg BRAF
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
117
|
25
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
117
|
25
|
Reasons for withdrawal
| Measure |
Binimetinib 45 mg BRAF
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
26
|
93
|
17
|
|
Overall Study
Adverse Event
|
12
|
20
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
1
|
|
Overall Study
Administrative problems
|
0
|
0
|
1
|
Baseline Characteristics
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.7 Years
STANDARD_DEVIATION 14.59 • n=5 Participants
|
59.6 Years
STANDARD_DEVIATION 13.74 • n=7 Participants
|
51.3 Years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
57.1 Years
STANDARD_DEVIATION 13.82 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
41 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause, whichever occurred first (maximum duration of up to 33 months)Population: The full analysis set included all randomized participants who received at least one dose of study drug.
Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.0, was defined as participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (OR)
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
14.5 percentage of participants
Interval 8.7 to 22.2
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
SECONDARY outcome
Timeframe: From date of randomization or date of start of treatment until date of first documentation of PD or date of death due to any cause or date of data censoring, whichever occurred first (maximum duration of up to 33 months)Population: The full analysis set included all randomized participants who received at least one dose of study drug.
PFS as assessed by investigator per RECIST v1.0, was defined as time (in months) from date of randomization or date of start of treatment to first documentation of PD or date of death due to any cause or data censoring date, whichever occurred first. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (\>=) 5 mm, or appearance of \>=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. If a participant did not had an event, data censoring was done at the date of last adequate tumor assessment. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
3.5 months
Interval 1.9 to 3.8
|
3.6 months
Interval 2.6 to 3.8
|
1.8 months
Interval 1.5 to 3.7
|
SECONDARY outcome
Timeframe: From date of randomization or date of start of treatment to date of death due to any cause or date of censoring, whichever occurred first (maximum duration of up to 33 months)Population: The full analysis set included all randomized participants who received at least one dose of study drug.
Overall survival was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Median, upper limit and lower limit of 95% Confidence Interval (CI) could not be estimated due to less number of participants with event.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to less number of participants with event.
|
16.6 months
Interval 4.9 to
The upper limit of 95% CI could not be estimated due to less number of participants with event.
|
SECONDARY outcome
Timeframe: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum duration of up to 33 months)Population: The full analysis set included all randomized participants who received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
DOR:time from first documentation of OR (confirmed CR or PR) to first documentation of PD/death due to any cause/data censoring date,whichever occurred first. As per RECIST v1.0, CR:disappearance of all target(T) and non-target (Non-T) lesions sustained for =\>4 weeks. Any pathological lymph nodes(T or non-T) reduced in short axis to \<10mm. PR:\>=30% decrease in sum of diameters(SOD) of T lesions, taking as reference baseline SOD. PD for T lesions:at least a 20% increase in sum of diameters of T lesions, taking as reference smallest sum on study treatment, with absolute increase of \>=5 mm,or appearance of \>=1 new lesions.PD for Non-T lesions:unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy/appearance of new unequivocal malignant lesion.Data was censored on date of last adequate tumor assessment for participants without an event,who started new anti-cancer treatment prior to assessment,who missed \>=2 tumor assessments.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=2 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=17 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=3 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
3.6 months
Interval 3.6 to 3.7
|
4.0 months
Interval 3.7 to
The upper limit of 95% CI could not be estimated due to less number of participants with event.
|
NA months
Median, upper limit and lower limit of 95% CI could not be estimated due to less number of participants with event.
|
SECONDARY outcome
Timeframe: From the date of randomization or date of start of treatment to the first documentation of objective response (CR or PR) or data censoring date, whichever occurred first (maximum duration of up to 33 months)Population: The full analysis set included all randomized participants who received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
TTR as assessed by investigator according to RECIST v1.0, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=2 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=17 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=3 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Time to Response (TTR)
|
2.2 months
Interval 1.8 to 2.5
|
1.9 months
Interval 1.8 to 3.7
|
1.8 months
Interval 1.8 to 1.8
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment.
Adverse drug reaction (ADR) was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4:life-threatening consequence, urgent intervention indicated; Grade 5:death related to study drug. Treatment-emergent ADRs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent ADR were reported in this outcome measure.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Reactions Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.0
|
19 Participants
|
52 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment.
A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying) ; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly, important medical event.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Reactions
|
2 Participants
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment.
Hematology per NCI-CTCAE included, Lymphocyte count decreased-(G1:\<0.8, G2:\<0.8-0.5, G3:\<0.5-0.2, G4:\<0.2\[\*10\^9/L\]); Lymphocyte count increased-(G2:\>4-20, G3:\>20\[\*10\^9/L\]); Neutrophil count decreased-(G1:\<1.5, G2:\<1.5-1.0, G3:\<1.0-0.5, G4:\<0.5\[\*10\^9/L\]); Activated partial thromboplastin time prolonged (seconds)-(G1:\>1.5\*upper limit normal (ULN), G2:\>1.5-2.5\*ULN, G3:\>2.5\*ULN); Platelet count decreased-(G1:\<75.0, G2:\<75.0-50.0, G3:\<50.0-25.0, G4:\<25.0\[\*10\^9/L\]); Fibrinogen decreased-(G1:\<1.0-0.75\*lower limit normal (LLN), G2:\<0.75-0.5\*LLN, G3:\<0.5-0.25\*LLN G4:\<0.25\*LLN); Anemia-(G1:\<LLN-100, G2:\<100-80, G3:\<80 \[g/L\], G4:Life-threatening, G5:death); Hemoglobin increased-(G1:\>0-2 g/dL above ULN, G2:\>2-4 g/dL above ULN, G3:\>4 g/dL above ULN); Prothrombin time (INR) increased-(G1:\>1-1.5, G2:\>1.5-2.5, G3:\>2.5\[\*ULN\]); WBC decreased-(G1:\<3.0\*10\^9/L, G2:\<3.0-2.0\*10\^9/L, G3:\<2.0-1.0\*10\^9/L, G4:\<1.0\*10\^9/L); WBC increased-(G3:\>100,000/mm3, G4:Clinical manifestations of increase in WBC, G5:death).
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 1 baseline to Grade 1 post-baseline
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 1 baseline to Grade 2 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 2 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: 'Missing' baseline to Grade 0 post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: 'Missing' baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 1 baseline to Grade 1 post-baseline
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 2 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 0 baseline to Grade 1 post-baseline
|
10 Participants
|
35 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin increased: Grade 0 baseline to Grade 0 post-baseline
|
40 Participants
|
115 Participants
|
24 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin increased: Grade 0 baseline to Grade 1 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: 'Missing' baseline to Grade 0 post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: 'Missing' baseline to 'Missing' post-baseline
|
1 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 1 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 2 baseline to Grade 1 post-baseline
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) increased: Grade 0 baseline to Grade 0 post-baseline
|
40 Participants
|
117 Participants
|
24 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 0 baseline to Grade 0 post-baseline
|
28 Participants
|
63 Participants
|
10 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 0 baseline to Grade 1 post-baseline
|
1 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 0 baseline to Grade 2 post-baseline
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 1 baseline to Grade 0 post-baseline
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 1 baseline to Grade 1 post-baseline
|
3 Participants
|
12 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 1 baseline to Grade 2 post-baseline
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 1 baseline to Grade 3 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 2 baseline to Grade 0 post-baseline
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 2 baseline to Grade 1 post-baseline
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 2 baseline to Grade 2 post-baseline
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 3 baseline to Grade 2 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: Grade 3 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes decreased: 'Missing' baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes increased: Grade 0 baseline to Grade 0 post-baseline
|
36 Participants
|
110 Participants
|
22 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes increased: Grade 0 baseline to Grade 2 post-baseline
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes increased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Lymphocytes increased: 'Missing' baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 0 baseline to Grade 0 post-baseline
|
38 Participants
|
100 Participants
|
21 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 0 baseline to Grade 1 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 1 baseline to Grade 1 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 1 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 1 baseline to Grade 3 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 2 baseline to Grade 1 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 3 baseline to Grade 1 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 3 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): Grade 4 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): 'Missing' baseline to Grade 0 post-baseline
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Absolute Neutrophils (Segmented and Bands): 'Missing' baseline to 'Missing' post-baseline
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 0 baseline to Grade 0 post-baseline
|
31 Participants
|
96 Participants
|
19 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 0 baseline to Grade 1 post-baseline
|
3 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 0 baseline to Grade 3 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Activated partial thromboplastin time: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 0 baseline to Grade 0 post-baseline
|
36 Participants
|
97 Participants
|
21 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 0 baseline to Grade 1 post-baseline
|
2 Participants
|
14 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Platelet count (Direct): 'Missing' baseline to Grade 0 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 0 baseline to Grade 0 post-baseline
|
8 Participants
|
19 Participants
|
8 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 0 baseline to Grade 1 post-baseline
|
11 Participants
|
52 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 0 baseline to Grade 2 post-baseline
|
10 Participants
|
32 Participants
|
7 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 0 baseline to Grade 4 post-baseline
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: 'Missing' baseline to Grade 0 post-baseline
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Fibrinogen decreased: 'Missing' baseline to 'Missing' post-baseline
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 0 baseline to Grade 0 post-baseline
|
3 Participants
|
22 Participants
|
7 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 0 baseline to Grade 2 post-baseline
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 1 baseline to Grade 1 post-baseline
|
16 Participants
|
27 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 1 baseline to Grade 2 post-baseline
|
5 Participants
|
16 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 2 baseline to Grade 1 post-baseline
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 2 baseline to Grade 2 post-baseline
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin decreased: Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Haemoglobin increased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 0 baseline to Grade 0 post-baseline
|
15 Participants
|
40 Participants
|
11 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 0 baseline to Grade 1 post-baseline
|
20 Participants
|
56 Participants
|
9 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 0 baseline to Grade 3 post-baseline
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 0 baseline to 'Missing' post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 1 baseline to Grade 1 post-baseline
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 2 baseline to Grade 2 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
Prothrombin time: Grade 3 baseline to Grade 3 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 0 baseline to Grade 0 post-baseline
|
35 Participants
|
93 Participants
|
20 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 0 baseline to Grade 1 post-baseline
|
2 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 1 baseline to Grade 0 post-baseline
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 1 baseline to Grade 1 post-baseline
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total) decreased: Grade 2 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Hematology)
WBC (Total)- increased: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 11 years, approximately)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment.
Albumin(G1:\<30,G2:\<30-20,G3:\<20\[g/L\], G4:life-threatening, G5:death);Alkaline phosphatase(G1:\>2.5,G2:\>2.5-5.0,G3:\>5.0-20.0, G4:\>20.0\[\*ULN\]);Creatine kinase(G1:\>2.5,G2:\>2.5-5,G3:\>5-10,G4:\>10\[\*ULN\]);Creatinine(CT) clearance(G1:\<LLN-60,G2:59-30,G3:29-15,G3:\<15\[ml/min/1.73m\^2\], G5:death);CT (G1:\>1.5,G2:\>1.5-3.0,G3:\>3.0-6.0,G4:\>6.0\[\*ULN\]);Hypomagnesemia(G1:\<0.5,G2:\<0.5-0.4,G3:\<0.4-0.3,G4:\<0.3\[mmol/L\],G5:death);Hypermagnesemia(G1:\>1.23,G3:\>1.23-3.30, G4:\>3.30\[mmol/L\],G5:death);Hypophosphatemia(G1:\<0.8,G2:\<0.8-0.6,G3:\<0.6-0.3,G4:\<0.3\[mmol/L\], G5:death);Hypokalemia(G1:\<3.0,G2:\<3.0,G3:\<3.0-2.5,G4:\<2.5\[mmol/L\],G5:death);Hyperkalemia(G1:\>5.5,G2:\>5.5-6.0,G3:\>6.0-7.0, G4:\>7.0\[mmol/L\],G5:death);AST(G1:\>3.0,G2:\>3.0-5.0,G3:\>5.0-20.0,G4:\>20.0\[\*ULN\]); ALT(G1:\>3.0,G2:\>3.0-5.0,G3:\>5.0-20.0,G4:\>20.0\[\*ULN\]);Hyponatremia(G1:\<130,G3:\<130-120,G4:\<120\[mmol/L\],G5:death);Hypernatremia(G1:150,G2:\>150-155,G3:\>155-160,G4:\>160\[mmol/L\],G5:death);High blood bilirubin (G1:\>1.5,G2:\>1.5-3.0,G3:\>3.0-10.0,G4:\>10.0\[\*ULN\]).
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypermagnesemia: 'Missing' baseline to Grade 0 post-baseline
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 1 baseline to Grade 1 post-baseline
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 0 baseline to Grade 1 post-baseline
|
7 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 0 baseline to Grade 3 post-baseline
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 1 baseline to Grade 0 post-baseline
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 1 baseline to Grade 1 post-baseline
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 3 baseline to Grade 4 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 0 baseline to Grade 0 post-baseline
|
14 Participants
|
43 Participants
|
11 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 0 baseline to Grade 1 post-baseline
|
13 Participants
|
41 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 0 baseline to Grade 2 post-baseline
|
4 Participants
|
19 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 1 baseline to Grade 1 post-baseline
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 1 baseline to Grade 2 post-baseline
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 2 baseline to Grade 0 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 2 baseline to Grade 2 post-baseline
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: Grade 2 baseline to Grade 3 post-baseline
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: 'Missing' baseline to Grade 0 post-baseline
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: 'Missing' baseline to Grade 1 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Albumin: 'Missing' baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 0 baseline to Grade 0 post-baseline
|
0 Participants
|
44 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 0 baseline to Grade 1 post-baseline
|
0 Participants
|
21 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: 'Missing' baseline to Grade 1 post-baseline
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 1 baseline to Grade 1 post-baseline
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 1 baseline to Grade 2 post-baseline
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 2 baseline to Grade 1 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 2 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: Grade 3 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: 'Missing' baseline to Grade 0 post-baseline
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: 'Missing' baseline to Grade 1 post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Alkaline phosphatase, serum: 'Missing' baseline to 'Missing' post-baseline
|
41 Participants
|
31 Participants
|
21 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 0 baseline to Grade 0 post-baseline
|
10 Participants
|
20 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 0 baseline to Grade 1 post-baseline
|
11 Participants
|
34 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 0 baseline to Grade 2 post-baseline
|
6 Participants
|
27 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 0 baseline to Grade 3 post-baseline
|
4 Participants
|
13 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 0 baseline to Grade 4 post-baseline
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 0 baseline to 'Missing' post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 1 baseline to Grade 3 post-baseline
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 1 baseline to Grade 4 post-baseline
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: 'Missing' baseline to Grade 2 post-baseline
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: 'Missing' baseline to Grade 3 post-baseline
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: 'Missing' baseline to 'Missing' post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 0 baseline to Grade 0 post-baseline
|
22 Participants
|
57 Participants
|
16 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 0 baseline to Grade 1 post-baseline
|
5 Participants
|
17 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 0 baseline to Grade 2 post-baseline
|
2 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 0 baseline to Grade 4 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 1 baseline to Grade 1 post-baseline
|
6 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 1 baseline to Grade 2 post-baseline
|
1 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 2 baseline to Grade 1 post-baseline
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 2 baseline to Grade 2 post-baseline
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: Grade 2 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine Clearance: 'Missing' baseline to 'Missing' post-baseline
|
0 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 0 baseline to Grade 0 post-baseline
|
9 Participants
|
12 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 0 baseline to Grade 1 post-baseline
|
27 Participants
|
91 Participants
|
16 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 2 baseline to Grade 1 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 0 baseline to Grade 2 post-baseline
|
1 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 1 baseline to Grade 1 post-baseline
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatinine: Grade 1 baseline to Grade 2 post-baseline
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Creatine Kinase: Grade 2 baseline to Grade 4 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 0 baseline to Grade 0 post-baseline
|
30 Participants
|
78 Participants
|
22 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 0 baseline to Grade 1 post-baseline
|
4 Participants
|
21 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 0 baseline to 'Missing' post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 1 baseline to Grade 1 post-baseline
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: Grade 1 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: 'Missing' baseline to Grade 0 post-baseline
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: 'Missing' baseline to Grade 1 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypomagnesemia: 'Missing' baseline to 'Missing' post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypermagnesemia: Grade 0 baseline to Grade 0 post-baseline
|
35 Participants
|
108 Participants
|
22 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypermagnesemia: Grade 0 baseline to Grade 1 post-baseline
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypermagnesemia: Grade 0 baseline to 'Missing' post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypermagnesemia: Grade 3 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypermagnesemia: 'Missing' baseline to 'Missing' post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 0 baseline to Grade 0 post-baseline
|
36 Participants
|
79 Participants
|
20 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 0 baseline to Grade 1 post-baseline
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 1 baseline to Grade 1 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 0 baseline to 'Missing' post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 1 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 2 baseline to Grade 0 post-baseline
|
0 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 2 baseline to Grade 2 post-baseline
|
0 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypophosphatemia (Inorganic Phosphorus): 'Missing' baseline to Grade 0 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 0 baseline to Grade 0 post-baseline
|
33 Participants
|
93 Participants
|
18 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 0 baseline to Grade 2 post-baseline
|
3 Participants
|
19 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 0 baseline to Grade 3 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 0 baseline to Grade 4 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 2 baseline to Grade 0 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 2 baseline to Grade 2 post-baseline
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypokalemia: Grade 2 baseline to Grade 4 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 0 baseline to Grade 0 post-baseline
|
35 Participants
|
104 Participants
|
21 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 0 baseline to Grade 1 post-baseline
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 0 baseline to Grade 4 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 1 baseline to Grade 1 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyperkalemia: Grade 2 baseline to Grade 0 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 0 baseline to Grade 0 post-baseline
|
11 Participants
|
33 Participants
|
5 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 0 baseline to Grade 1 post-baseline
|
24 Participants
|
67 Participants
|
13 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 0 baseline to Grade 4 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 1 baseline to Grade 2 post-baseline
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: Grade 3 baseline to Grade 3 post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
AST: 'Missing' baseline to Grade 1 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 0 baseline to Grade 0 post-baseline
|
20 Participants
|
58 Participants
|
15 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 0 baseline to Grade 1 post-baseline
|
17 Participants
|
39 Participants
|
5 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 0 baseline to Grade 4 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 1 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 1 baseline to Grade 1 post-baseline
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 1 baseline to Grade 2 post-baseline
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
ALT: Grade 2 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 0 baseline to Grade 0 post-baseline
|
25 Participants
|
92 Participants
|
17 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 1 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hyponatremia: Grade 3 baseline to Grade 3 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypernatremia: Grade 0 baseline to Grade 0 post-baseline
|
37 Participants
|
101 Participants
|
24 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypernatremia: Grade 0 baseline to Grade 1 post-baseline
|
2 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypernatremia: Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Hypernatremia: Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 0 baseline to Grade 0 post-baseline
|
36 Participants
|
105 Participants
|
22 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 0 baseline to Grade 1 post-baseline
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 0 baseline to Grade 2 post-baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 0 baseline to Grade 4 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Chemistries)
Bilirubin (total) increased: Grade 0 baseline to 'Missing' post-baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (up to maximum of 33 months)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment.
Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 0 baseline to Grade 1 post-baseline
|
7 Participants
|
23 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 0 baseline to Grade 2 post-baseline
|
5 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 0 baseline to Grade 3 post-baseline
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 0 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 0 baseline to Grade 0 post-baseline
|
4 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 0 baseline to Grade 1 post-baseline
|
7 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 0 baseline to Grade 2 post-baseline
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 0 baseline to Grade 3 post-baseline
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 1 baseline to Grade 0 post-baseline
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 1 baseline to Grade 1 post-baseline
|
10 Participants
|
29 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 1 baseline to Grade 2 post-baseline
|
7 Participants
|
23 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 1 baseline to Grade 3 post-baseline
|
2 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 1 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 2 baseline to Grade 1 post-baseline
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 2 baseline to Grade 2 post-baseline
|
3 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 2 baseline to Grade 3 post-baseline
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 2 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 3 baseline to Grade 2 post-baseline
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting SBP (millimeters of mercury): Grade 3 baseline to Grade 3 post-baseline
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 0 baseline to Grade 0 post-baseline
|
9 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 1 baseline to Grade 0 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 1 baseline to Grade 1 post-baseline
|
5 Participants
|
19 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 1 baseline to Grade 2 post-baseline
|
5 Participants
|
17 Participants
|
5 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 1 baseline to Grade 3 post-baseline
|
1 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 1 baseline to 'Missing' post-baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 2 baseline to Grade 0 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 2 baseline to Grade 1 post-baseline
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 2 baseline to Grade 2 post-baseline
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 2 baseline to Grade 3 post-baseline
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 3 baseline to Grade 2 post-baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 (Blood Pressure)
Sitting DBP (millimeters of mercury): Grade 3 baseline to Grade 3 post-baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (up to maximum of 33 months)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Pre-defined criteria of markedly abnormal vital signs abnormalities was defined as increase or decrease from baseline (\>=15 beats per minute) in pulse rate of \>=120 beats per minute or less than or equal to (\<=) 50 beats per minute.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=39 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=116 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=24 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Sign Values: Sitting Pulse Rate
Sitting pulse (High only) (beats per minute)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Values: Sitting Pulse Rate
Sitting pulse (Low only) (beats per minute)
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Values: Sitting Pulse Rate
Sitting pulse (High and Low) (beats per minute)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (up to maximum of 33 months)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Vital signs included assessment of body weight. Body weight (in kilograms) measurements included high and low. Pre-defined criteria of markedly abnormal vital signs abnormalities was defined as increase or decrease from baseline in weight of \>=10%.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=39 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=24 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Sign Values: Weight
Weight (Low)
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Sign Values: Weight
Weight (High)
|
6 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (up to maximum of 33 months)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. Here 'number analyzed' signifies participants with available data for each specified category.
ECG findings included maximum value of \>450 millisecond (msec), \>480 msec and \>500 msec, increase from baseline \>30 msec and \>60 msec for QT interval corrected using Fridericia's formula (QTcF); maximum value of \>450 msec, \>480 msec and \>500 msec, increase from baseline \>30 msec and \>60 msec for QT interval corrected using Bazett's formula (QTcB); maximum value of \>450 msec, \>480 msec and \>500 msec, increase from baseline \>30 msec and \>60 msec for QT interval; RR decrease \>25% and to a VR \>100, RR increase \>25% and to a VR \<50 beats per minute for VR interval; an increase \>25% and to a value \>200 msec for PR interval; an increase \>25% and to a value \>110 msec for QRS interval.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcF (millisecond): New >450
|
5 Participants
|
15 Participants
|
3 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcF (millisecond): New >480
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcF (millisecond): New >500
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcF (millisecond): Increase from baseline >30
|
4 Participants
|
24 Participants
|
5 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcF (millisecond): Increase from baseline >60
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcB (millisecond): New >450
|
4 Participants
|
26 Participants
|
6 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcB (millisecond): New >480
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcB (millisecond): New >500
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcB (millisecond): Increase from baseline >30
|
6 Participants
|
29 Participants
|
6 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QTcB (millisecond): Increase from baseline >60
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QT (millisecond): New >450
|
6 Participants
|
13 Participants
|
1 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QT (millisecond): New >480
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QT (millisecond): New >500
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QT (millisecond): Increase from baseline >30
|
14 Participants
|
54 Participants
|
9 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QT (millisecond): Increase from baseline >60
|
3 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
VR (beats per minute): RR decrease >25% & to a VR >100
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
VR (beats per minute): RR increase >25% & to a VR <50
|
3 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
PR (millisecond): Increase >25% & to a value >200
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Notable Electrocardiogram (ECG) Values
QRS (millisecond): Increase >25% & to a value >110
|
1 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 33 months)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. Here 'number analyzed' signifies participants with available data for each specified category.
Fundoscopy examination included an examination of the retina, vitreous, macula, optic nerve, optic nerve pallor, choroid and other new abnormalities in either or both eyes. New abnormalities were identified where the baseline assessment showed no abnormalities in a particular eye, but at the post-dose time point an abnormality was observed. New abnormalities at any time point were reported and included unscheduled assessments.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Retina: New abnormalities (At any time)
|
10 Participants
|
43 Participants
|
13 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Vitreous: New abnormalities (At any time)
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Macula: New abnormalities (At any time)
|
7 Participants
|
39 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Optic Nerve: New abnormalities (At any time)
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Optic Nerve Pallor: New abnormalities (At any time)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Choroid: New abnormalities (At any time)
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Fundoscopy
Other: New abnormalities (At any time)
|
0 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (for a maximum duration of up to 33 months)Population: Safety analysis set included all participants who had received at least one dose of study drug and had at least one valid post-baseline safety assessment. Here 'number analyzed' signifies participants with available data for each specified category.
Slit lamp examination included an examination of the conjunctiva, cornea, iris, lens, anterior chamber, lids and other new abnormalities in either or both eyes. New abnormalities were identified where the baseline assessment showed no abnormalities in a particular eye, but at the post-dose time point an abnormality was observed. New abnormalities at any time point were reported and included unscheduled assessments.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=41 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Conjunctiva: New abnormalities (At any time)
|
4 Participants
|
25 Participants
|
7 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Cornea: New abnormalities (At any time)
|
3 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Iris: New abnormalities (At any time)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Lens: New abnormalities (At any time)
|
5 Participants
|
17 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Anterior chamber: New abnormalities (At any time)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Lids: New abnormalities (At any time)
|
6 Participants
|
25 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Abnormal Ophthalmoscopy Values- by Slit Lamp Examination
Other: New abnormalities (At any time)
|
1 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: Pharmacokinetic (PK) analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval at Steady-State (AUCtau) of Binimetinib
Cycle 1, Day 1
|
1606.73 hours*nanogram per milliliter
Geometric Coefficient of Variation 42.55
|
1704.80 hours*nanogram per milliliter
Geometric Coefficient of Variation 20.37
|
1587.47 hours*nanogram per milliliter
Geometric Coefficient of Variation 42.49
|
|
Area Under the Curve From Time Zero to End of Dosing Interval at Steady-State (AUCtau) of Binimetinib
Cycle 1, Day 15
|
2438.22 hours*nanogram per milliliter
Geometric Coefficient of Variation NA
The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
2051.70 hours*nanogram per milliliter
Geometric Coefficient of Variation 32.63
|
2637.48 hours*nanogram per milliliter
Geometric Coefficient of Variation 22.04
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Binimetinib
Cycle 1, Day 1
|
445.8 nanogram per milliliter
Geometric Coefficient of Variation 45.8
|
471.6 nanogram per milliliter
Geometric Coefficient of Variation 34.4
|
542.5 nanogram per milliliter
Geometric Coefficient of Variation 29.6
|
|
Maximum Plasma Concentration (Cmax) of Binimetinib
Cycle 1, Day 15
|
385.2 nanogram per milliliter
Geometric Coefficient of Variation 50.1
|
479.7 nanogram per milliliter
Geometric Coefficient of Variation 41.1
|
531.3 nanogram per milliliter
Geometric Coefficient of Variation 44.0
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Binimetinib
Cycle 1, Day 1
|
0.68 hours
Interval 0.5 to 3.25
|
1.50 hours
Interval 0.5 to 3.0
|
0.75 hours
Interval 0.5 to 7.98
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Binimetinib
Cycle 1, Day 15
|
1.50 hours
Interval 0.75 to 3.17
|
1.48 hours
Interval 0.42 to 8.0
|
1.42 hours
Interval 0.0 to 5.17
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-last) of Binimetinib
Cycle 1, Day 1
|
1318.38 hours*nanogram per milliliter
Geometric Coefficient of Variation 47.38
|
1447.07 hours*nanogram per milliliter
Geometric Coefficient of Variation 21.34
|
1622.66 hours*nanogram per milliliter
Geometric Coefficient of Variation 37.46
|
|
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-last) of Binimetinib
Cycle 1, Day 15
|
1806.28 hours*nanogram per milliliter
Geometric Coefficient of Variation 40.86
|
1832.06 hours*nanogram per milliliter
Geometric Coefficient of Variation 30.71
|
2263.46 hours*nanogram per milliliter
Geometric Coefficient of Variation 39.84
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
The Last Time Point of the Last Quantifiable Concentration (Tlast) of Binimetinib
Cycle 1, Day 1
|
7.23 hours
Interval 3.23 to 8.0
|
7.98 hours
Interval 7.03 to 8.05
|
7.00 hours
Interval 3.0 to 8.28
|
|
The Last Time Point of the Last Quantifiable Concentration (Tlast) of Binimetinib
Cycle 1, Day 15
|
7.50 hours
Interval 7.0 to 8.17
|
8.00 hours
Interval 7.02 to 8.43
|
7.50 hours
Interval 3.58 to 8.25
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) on Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Ctrough refers to plasma concentration of Binimetinib observed just before treatment administration.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=65 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=20 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of Binimetinib
|
127.0 nanogram per milliliter
Geometric Coefficient of Variation 69.6
|
102.3 nanogram per milliliter
Geometric Coefficient of Variation 79.1
|
136.1 nanogram per milliliter
Geometric Coefficient of Variation 67.2
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Drug clearance was defined as a quantitative measure of the rate at which a drug substance was removed from the plasma. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Binimetinib
Cycle 1, Day 1
|
28.01 liter/hour
Geometric Coefficient of Variation 46.90
|
26.40 liter/hour
Geometric Coefficient of Variation 20.98
|
37.80 liter/hour
Geometric Coefficient of Variation 30.48
|
|
Apparent Total Body Clearance (CL/F) of Binimetinib
Cycle 1, Day 15
|
18.46 liter/hour
Geometric Coefficient of Variation NA
The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
20.50 liter/hour
Geometric Coefficient of Variation 26.73
|
21.17 liter/hour
Geometric Coefficient of Variation 24.18
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval at Steady-State (AUCtau) of Binimetinib's Metabolite
Cycle 1, Day 1
|
257.73 hours*nanogram per milliliter
Geometric Coefficient of Variation 7.43
|
170.11 hours*nanogram per milliliter
Geometric Coefficient of Variation 12.96
|
248.82 hours*nanogram per milliliter
Geometric Coefficient of Variation 18.33
|
|
Area Under the Curve From Time Zero to End of Dosing Interval at Steady-State (AUCtau) of Binimetinib's Metabolite
Cycle 1, Day 15
|
—
|
253.93 hours*nanogram per milliliter
Geometric Coefficient of Variation NA
The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
322.21 hours*nanogram per milliliter
Geometric Coefficient of Variation NA
The geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Binimetinib's Metabolite
Cycle 1, Day 1
|
56.37 nanogram per milliliter
Geometric Coefficient of Variation 39.22
|
49.42 nanogram per milliliter
Geometric Coefficient of Variation 26.49
|
56.71 nanogram per milliliter
Geometric Coefficient of Variation 47.62
|
|
Maximum Plasma Concentration (Cmax) of Binimetinib's Metabolite
Cycle 1, Day 15
|
32.31 nanogram per milliliter
Geometric Coefficient of Variation 78.98
|
33.55 nanogram per milliliter
Geometric Coefficient of Variation 58.34
|
25.47 nanogram per milliliter
Geometric Coefficient of Variation 76.76
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Binimetinib's Metabolite
Cycle 1, Day 1
|
1.50 hours
Interval 0.5 to 3.25
|
1.50 hours
Interval 0.5 to 3.0
|
1.50 hours
Interval 0.5 to 7.98
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Binimetinib's Metabolite
Cycle 1, Day 15
|
2.50 hours
Interval 0.75 to 3.17
|
1.50 hours
Interval 0.5 to 8.0
|
1.50 hours
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-last) of Binimetinib's Metabolite
Cycle 1, Day 1
|
197.29 hours*nanogram per milliliter
Geometric Coefficient of Variation 46.15
|
181.60 hours*nanogram per milliliter
Geometric Coefficient of Variation 29.22
|
189.37 hours*nanogram per milliliter
Geometric Coefficient of Variation 50.78
|
|
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-last) of Binimetinib's Metabolite
Cycle 1, Day 15
|
157.35 hours*nanogram per milliliter
Geometric Coefficient of Variation 63.36
|
129.13 hours*nanogram per milliliter
Geometric Coefficient of Variation 62.80
|
87.11 hours*nanogram per milliliter
Geometric Coefficient of Variation 79.73
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 0.5, 1.5, 3, 8 hours on Day 1 and Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here 'number analyzed' signifies participants with available data for each specified category.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=37 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=105 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=23 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
The Last Time Point of the Last Quantifiable Concentration (Tlast) of Binimetinib's Metabolite
Cycle 1, Day 1
|
7.23 hours
Interval 3.23 to 8.0
|
7.98 hours
Interval 7.03 to 8.05
|
7.00 hours
Interval 3.0 to 8.28
|
|
The Last Time Point of the Last Quantifiable Concentration (Tlast) of Binimetinib's Metabolite
Cycle 1, Day 15
|
7.50 hours
Interval 7.0 to 8.17
|
8.00 hours
Interval 2.97 to 8.43
|
7.25 hours
Interval 1.42 to 8.25
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) on Day 15 of Cycle 1Population: PK analysis set included all participants who had at least one blood sample providing evaluable PK data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Ctrough refers to plasma concentration of Binimetinib's metabolite observed just before treatment administration.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=25 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=65 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=20 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of Binimetinib's Metabolite
|
12.85 nanogram per milliliter
Geometric Coefficient of Variation 80.44
|
11.63 nanogram per milliliter
Geometric Coefficient of Variation 123.41
|
16.10 nanogram per milliliter
Geometric Coefficient of Variation 104.21
|
SECONDARY outcome
Timeframe: Baseline up to maximum duration of up to 33 monthsPopulation: The full analysis set included all randomized participants who received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Percent change from baseline in H-score for pERK from tumor samples was assessed and summarized. The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=3 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=8 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=4 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Percent Change From Baseline in Histological Score (H-score) for Phosphorylated Extracellular Signal-Regulated Kinase (pERK) From Tumor Samples of Cytoplasmic and Nuclear Cellular Compartment
Cytoplasmic: Percent change from baseline
|
-10.90 percent change
Standard Deviation 26.460
|
-50.11 percent change
Standard Deviation 22.576
|
-9.85 percent change
Standard Deviation 59.566
|
|
Percent Change From Baseline in Histological Score (H-score) for Phosphorylated Extracellular Signal-Regulated Kinase (pERK) From Tumor Samples of Cytoplasmic and Nuclear Cellular Compartment
Nuclear: Percent change from baseline
|
195.19 percent change
Standard Deviation 219.585
|
-66.83 percent change
Standard Deviation 47.524
|
-32.35 percent change
Standard Deviation 83.258
|
SECONDARY outcome
Timeframe: Baseline up to maximum duration of up to 33 monthsPopulation: The full analysis set included all randomized participants who received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
The percentage change in DUSP6 gene expression was derived from the Relative Expression Ratio (RER) computed via the Delta Ct method. DUSP6, a protein coding gene was used as a biomarker of inhibition of the mitogen-activated protein kinase (MEK) pathway.
Outcome measures
| Measure |
Binimetinib 45 mg BRAF
n=3 Participants
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=8 Participants
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=3 Participants
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Percent Change From Baseline in Delta CT Values for Dual Specificity Phosphatase 6 (DUSP6) Expression From Tumor Samples
|
-50.25 percent change
Standard Deviation 12.069
|
-30.82 percent change
Standard Deviation 42.836
|
29.48 percent change
Standard Deviation 73.145
|
Adverse Events
Binimetinib 45 mg BRAF
Serious events: 11 serious events
Other events: 40 other events
Deaths: 5 deaths
Binimetinib 45 mg NRAS
Serious events: 39 serious events
Other events: 117 other events
Deaths: 51 deaths
Binimetinib 60 mg BRAF
Serious events: 9 serious events
Other events: 25 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Binimetinib 45 mg BRAF
n=41 participants at risk
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 participants at risk
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 participants at risk
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Face oedema
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
General physical health deterioration
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Malaise
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Performance status decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Hepatobiliary disorders
Hepatic pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Skin infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Heart rate irregular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Troponin T increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Seizure
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Haematoma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
Other adverse events
| Measure |
Binimetinib 45 mg BRAF
n=41 participants at risk
Participants with BRAF mutations received an oral dose of 45 milligrams (mg) of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 45 mg NRAS
n=117 participants at risk
Participants with NRAS mutations received an oral dose of 45 mg of binimetinib (3 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
Binimetinib 60 mg BRAF
n=25 participants at risk
Participants with BRAF mutations received an oral dose of 60 mg of binimetinib (4 tablets each of 15 mg) twice daily, for each 28 days treatment cycle until development of unacceptable toxicity, disease progression, treatment discontinuation by participant refusal or investigator's decision whichever occurred first. Participants were followed up to 30 days after last dose of study drug.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
4/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.5%
17/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
13.7%
16/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.9%
18/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
48.7%
57/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
52.0%
13/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Nausea
|
24.4%
10/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
31.6%
37/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
48.0%
12/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
4/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.9%
21/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
40.0%
10/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
19.7%
23/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.0%
4/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
11.1%
13/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.0%
5/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
7.7%
9/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.0%
7/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
7.7%
9/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Oedema peripheral
|
41.5%
17/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
51.3%
60/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
56.0%
14/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Fatigue
|
29.3%
12/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
34.2%
40/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
48.0%
12/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Pyrexia
|
12.2%
5/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
15.4%
18/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Face oedema
|
12.2%
5/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.4%
11/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.0%
5/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Asthenia
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.5%
10/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.4%
11/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood creatine phosphokinase increased
|
29.3%
12/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
51.3%
60/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
56.0%
14/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Aspartate aminotransferase increased
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.1%
20/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
15.4%
18/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.5%
10/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.5%
10/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.2%
5/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.2%
19/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
7.7%
9/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
28.0%
7/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
11.1%
13/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.0%
4/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
14/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Dysgeusia
|
22.0%
9/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.0%
7/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.0%
4/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.1%
6/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.0%
4/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.4%
11/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
5/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
36.6%
15/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
54.7%
64/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
32.0%
8/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.0%
16/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
21.4%
25/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.0%
5/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
4/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.9%
21/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
15.4%
18/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.0%
5/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.8%
15/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.8%
4/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
21.4%
25/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
24.0%
6/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Weight decreased
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Visual field defect
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.1%
6/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Left ventricular dysfunction
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Cleft lip
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Colour blindness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Congenital cleft hand
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Congenital optic nerve anomaly
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Corneal opacity congenital
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Congenital, familial and genetic disorders
Macular dystrophy congenital
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Amblyopia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Blepharitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Cataract
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Conjunctivitis allergic
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Conjunctivochalasis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Corneal scar
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Diplopia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Dry eye
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye allergy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye colour change
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye degenerative disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye discharge
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye irritation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eye swelling
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Eyelid oedema
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.1%
6/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Glaucoma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Lacrimation increased
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Macular oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Maculopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Ocular hypertension
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Ocular vascular disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Optic disc haemorrhage
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Orbital oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Papilloedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Paraneoplastic retinopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Periorbital oedema
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.5%
10/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.0%
4/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Photophobia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Photopsia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal cyst
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal detachment
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal exudates
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinopathy
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.3%
12/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
36.0%
9/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Retinoschisis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Trichiasis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Vision blurred
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.0%
7/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Visual impairment
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Vitreous detachment
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Peripheral swelling
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Vitreous disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Eye disorders
Vitreous floaters
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Eructation
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.0%
4/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Haematemesis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Intussusception
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Axillary pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Chest pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Chills
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Facial pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Feeling cold
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Gait disturbance
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
General physical health deterioration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Granuloma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Hypothermia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Inflammation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Influenza like illness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Localised oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Malaise
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Mucosal dryness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Mucous membrane disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Non-cardiac chest pain
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Performance status decreased
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Swelling
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Ulcer
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
General disorders
Xerosis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Body tinea
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Candida infection
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Cellulitis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Cystitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Erysipelas
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Influenza
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Lip infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Lung infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Oral herpes
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Orchitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Paronychia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Skin infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Viral infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Wound infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Anal injury
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Amylase increased
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood albumin increased
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.1%
6/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood potassium increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood pressure increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood urea increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Blood urine present
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.1%
6/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Intraocular pressure increased
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.0%
7/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Lipase increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Prothrombin time shortened
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Sinus rhythm
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Troponin T increased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Weight increased
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.3%
5/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.8%
8/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Migraine
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.0%
3/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Nocturia
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal odour
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Chronic pigmented purpura
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Eczema weeping
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.4%
4/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.0%
7/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash maculovesicular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.0%
7/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Erythromelalgia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Flushing
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Haematoma
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Hyperanemia
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Lymphoedema
|
7.3%
3/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.6%
3/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.0%
2/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Thrombophlebitis
|
2.4%
1/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.7%
2/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Investigations
Troponin increased
|
4.9%
2/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.85%
1/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/41 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/117 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.0%
1/25 • From baseline up to 30 days after last dose (for a maximum duration of up to 11 years, approximately)
Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER