Trial Outcomes & Findings for Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors (NCT NCT02228382)
NCT ID: NCT02228382
Last Updated: 2021-12-30
Results Overview
Confirmed MCyR: confirmed (complete cytogenetic response\[CCyR\] or partial cytogenetic response\[PCyR\]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments \>=28 days apart. CCyR: 0% Ph+ cells from \>=20 metaphases from conventional cytogenetics or \<1% Ph+ cells from \>= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: \<=0.1% BCR-ABL1 on the international scale (IS) with at least 10,000 ABL1 transcripts assessed by central laboratory.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
163 participants
Primary outcome timeframe
Up to 1 year (52 weeks)
Results posted on
2021-12-30
Participant Flow
Participants with chronic phase (CP), accelerated phase (AP), or blast phase (BP) philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML), or breakpoint cluster region-abelson kinase (BCR-ABL1) positive and Philadelphia chromosome negative (Ph-), who failed prior treatment with commercially available tyrosine kinase inhibitors (TKIs) due to drug resistance or intolerance, or were otherwise contraindicated for treatment with commercially available TKIs were enrolled.
A total of 177 participants signed the ICF, 14 participants were screen failure and 163 were enrolled into the study and assigned to study treatment. Reporting arms were based on line of therapy (CP2L, CP3L, CP4L) and disease phase (CP and AP). Data collection and planned analysis on BP participants was not performed because no participants with BP were enrolled in the study.
Participant milestones
| Measure |
Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia resistant or intolerant to imatinib, dasatinib, or nilotinib received bosutinib 500 milligram (mg), orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia resistant or intolerant to imatinib and/or dasatinib and/or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia resistant or intolerant to imatinib and dasatinib and nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia resistant or intolerant to at least one tyrosine kinase inhibitor among imatinib, dasatinib, or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
61
|
49
|
4
|
3
|
|
Overall Study
COMPLETED
|
36
|
43
|
28
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
21
|
2
|
2
|
Reasons for withdrawal
| Measure |
Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia resistant or intolerant to imatinib, dasatinib, or nilotinib received bosutinib 500 milligram (mg), orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia resistant or intolerant to imatinib and/or dasatinib and/or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia resistant or intolerant to imatinib and dasatinib and nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia resistant or intolerant to at least one tyrosine kinase inhibitor among imatinib, dasatinib, or nilotinib received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia received bosutinib 500 mg, orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, death or discontinuation of study (up to maximum of 4 years). Participants who discontinued bosutinib prior to completing at least 4 years of therapy were followed for survival until they completed at least 4 years of follow-up from the time of first dose.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
7
|
5
|
0
|
2
|
|
Overall Study
Participant refused further follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
3
|
5
|
7
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
1
|
0
|
|
Overall Study
Other
|
2
|
3
|
3
|
0
|
0
|
Baseline Characteristics
Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Baseline characteristics by cohort
| Measure |
Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 Participants
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.8 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
59.4 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
40.8 Years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
64.3 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
58.9 Years
STANDARD_DEVIATION 15.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
75 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
88 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
143 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year (52 weeks)Population: Evaluable set for cytogenetic response: treated participants with valid baseline efficacy assessment (\>=20 metaphases from baseline bone marrow or CCyR with \>=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for AP CML and Ph- participants and planned to be analyzed for 2nd line and 3rd line population.
Confirmed MCyR: confirmed (complete cytogenetic response\[CCyR\] or partial cytogenetic response\[PCyR\]) by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least major molecular response(MMR) by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments \>=28 days apart. CCyR: 0% Ph+ cells from \>=20 metaphases from conventional cytogenetics or \<1% Ph+ cells from \>= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: \<=0.1% BCR-ABL1 on the international scale (IS) with at least 10,000 ABL1 transcripts assessed by central laboratory.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=98 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 2nd and 3rd Line Chronic Phase (CP) Participants
|
76.5 percentage of participants
Interval 66.9 to 84.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1 year (52 weeks)Population: Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (\>= 20 metaphases from baseline bone marrow or CCyR with \>=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for AP CML and Ph-participants.
Confirmed MCyR: confirmed CCyR or PCyR by 1 year for participants entering the study without CCyR or maintenance of confirmed CCyR for at least 1 year after treatment start with bosutinib for participants entering the study with CCyR or at least MMR by 1 year and a deeper molecular response compared to baseline. Participants with baseline PCyR that did not achieve CCyR were counted as nonresponders. Initial cytogenetic (in absence of MMR) responses must have been confirmed by 2 consecutive assessments \>=28 days apart. CCyR: 0% Ph+ cells from \>=20 metaphases from conventional cytogenetics or \<1% Ph+ cells from \>= 200 cells from fluorescent in situ hybridization(FISH). PCyR: 1 to 35% Ph+ cells. MMR: \<=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=45 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Confirmed Major Cytogenetic Response (MCyR) in 4th or Later Line Chronic Phase (CP) Participants
|
62.2 percentage of participants
Interval 46.5 to 76.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1 year (52 weeks)Population: Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.
Confirmed OHR was defined as complete hematological response (CHR) or return to chronic phase (RCP) by 1 year in AP and BP participants. CHR was defined as white blood cells (WBC) \<10\*10\^9/L, peripheral blood basophils \<5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count \<450\*10\^9/L, spleen not palpable. Hematologic responses must be of \>=4 weeks duration confirmed by 2 assessments \>=4 weeks apart.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML) Participants
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (\>=20 metaphases from baseline bone marrow or CCyR with \>=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.
CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from \>=20 metaphases from conventional bone marrow cytogenetics or \<1% Ph+ cells from \>=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=43 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=55 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=45 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Major Cytogenetic Response (MCyR)
|
88.4 percentage of participants
Interval 74.9 to 96.1
|
85.5 percentage of participants
Interval 73.3 to 93.5
|
77.8 percentage of participants
Interval 62.9 to 88.8
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.
Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC \<10\*10\^9/L, peripheral blood basophils \<5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count \<450\*10\^9/L, spleen not palpable. Hematologic responses must be of \>=4 weeks duration confirmed by 2 assessments \>=4 weeks apart.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Confirmed Overall Hematological Response (OHR) in Participants With Accelerated Phase (AP) Chronic Myelogenous Leukemia (CML)
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Evaluable set:treated participants with valid baseline molecular, cytogenetic or hematologic assessment. Data for this outcome measure (all categories including OHR) was not planned to be collected and analyzed for Ph- CML participants. Data for OHR was not planned to be collected and analyzed for CP CML participants.
Hierarchy best response: %participants with best response among molecular/cytogenetic/hematologic response. Molecular response:MR4.5/MR4/MMR defined as \<=0.0032/0.01/0.1% BCR-ABL1 ratio on IS corresponding to \>=4.5/4/3-log reduction from standardised baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. CyR:based on prevalence of Ph+cells. CCyR: 0% Ph+cells from \>=20 metaphases from conventional cytogenetics or \<1%Ph+cells from \>=200 cells from FISH. PCyR:1 to 35% Ph+cells. CHR:WBC \<10\*10\^9/L, peripheral blood basophils\<5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in differential, platelet count\<450\*10\^9/L, spleen not palpable.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Best Response
MR4.5
|
17.4 percentage of participants
Interval 7.8 to 31.4
|
14.8 percentage of participants
Interval 7.0 to 26.2
|
8.2 percentage of participants
Interval 2.3 to 19.6
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Cumulative Best Response
MR4
|
15.2 percentage of participants
Interval 6.3 to 28.9
|
11.5 percentage of participants
Interval 4.7 to 22.2
|
6.1 percentage of participants
Interval 1.3 to 16.9
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
—
|
—
|
|
Percentage of Participants With Cumulative Best Response
MMR
|
8.7 percentage of participants
Interval 2.4 to 20.8
|
11.5 percentage of participants
Interval 4.7 to 22.2
|
14.3 percentage of participants
Interval 5.9 to 27.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Cumulative Best Response
CCyR
|
2.2 percentage of participants
Interval 0.1 to 11.5
|
13.1 percentage of participants
Interval 5.8 to 24.2
|
14.3 percentage of participants
Interval 5.9 to 27.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Cumulative Best Response
PCyR
|
2.2 percentage of participants
Interval 0.1 to 11.5
|
1.6 percentage of participants
Interval 0.0 to 8.8
|
4.1 percentage of participants
Interval 0.5 to 14.0
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
—
|
—
|
|
Percentage of Participants With Cumulative Best Response
CHR
|
10.9 percentage of participants
Interval 3.6 to 23.6
|
8.2 percentage of participants
Interval 2.7 to 18.1
|
16.3 percentage of participants
Interval 7.3 to 29.7
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
—
|
—
|
|
Percentage of Participants With Cumulative Best Response
OHR
|
—
|
—
|
—
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 3, 6, 12, 18, and 24Population: Evaluable set cytogenetic response: treated participants with valid baseline efficacy assessment (\>= 20 metaphases from baseline bone marrow or CCyR with \>=200 cells from FISH or baseline MMR). Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.
CyR was based on prevalence of Ph+ cells. CCyR was achieved when there was 0 % Ph+ cells from \>=20 metaphases from conventional bone marrow cytogenetics or \<1% Ph+ cells from \>=200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. MCyR was categorized as either CCyR or PCyR. Participants with MMR or better at baseline were counted as CCyR if baseline response was maintained or improved while on treatment.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=43 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=55 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=45 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24
At 3 months
|
81.4 percentage of participants
Interval 66.6 to 91.6
|
80.0 percentage of participants
Interval 67.0 to 89.6
|
55.6 percentage of participants
Interval 40.0 to 70.4
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24
At 6 months
|
69.8 percentage of participants
Interval 53.9 to 82.8
|
63.6 percentage of participants
Interval 49.6 to 76.2
|
62.2 percentage of participants
Interval 46.5 to 76.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24
At 12 months
|
69.8 percentage of participants
Interval 53.9 to 82.8
|
65.5 percentage of participants
Interval 51.4 to 77.8
|
48.9 percentage of participants
Interval 33.7 to 64.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24
At 18 months
|
67.4 percentage of participants
Interval 51.5 to 80.9
|
63.6 percentage of participants
Interval 49.6 to 76.2
|
42.2 percentage of participants
Interval 27.7 to 57.8
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) at Months 3, 6, 12, 18 and 24
At 24 months
|
67.4 percentage of participants
Interval 51.5 to 80.9
|
54.5 percentage of participants
Interval 40.6 to 68.0
|
44.4 percentage of participants
Interval 29.6 to 60.0
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12, 18, and 24Population: Evaluable set hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for CP2L, CP3L, CP4L and Ph- CML participants.
Confirmed OHR was defined as CHR or RCP in AP and BP participants. CHR was defined as WBC \<10\*10\^9/L, peripheral blood basophils \<5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count \<450\*10\^9/L, spleen not palpable. Hematologic responses must be of \>=4 weeks duration confirmed by 2 assessments \>=4 weeks apart.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
At 3 months
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
At 6 months
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
At 9 months
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
At 12 months
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
At 18 months
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Accelerated Phase Participants With Confirmed Overall Hematological Response (OHR) at Month 3, 6, 9, 12, 18, and 24
At 24 months
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Evaluable set for hematological response: treated participants with a valid baseline hematologic assessment. Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.
CHR was defined as WBC \<10\*10\^9/L, peripheral blood basophils \<5%, no peripheral blood myelocytes, promyelocytes, myeloblasts in the differential, platelet count \<450\*10\^9/L, spleen not palpable. Hematologic responses must be of \>=4 weeks duration confirmed by 2 assessments \>=4 weeks apart.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=48 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Confirmed Complete Hematological Response (CHR)
|
91.3 percentage of participants
Interval 79.2 to 97.6
|
82.0 percentage of participants
Interval 70.0 to 90.6
|
77.1 percentage of participants
Interval 62.7 to 88.0
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Evaluable set for molecular response: treated participants with a valid baseline molecular assessment. Data for this outcome measure was not planned to be collected and analyzed for Ph- participants.
Molecular response: MR4.5/MR4/MMR defined as \<=0.0032/0.01/0.1% BCR-ABL1 ratio respectively, on IS corresponding to \>=4.5/4/3-log reduction from standardized baseline with at least 32,000/10,000/10,000 ABL1 assessed by central laboratory. To be considered a responder, the participant must have had maintenance of baseline response while on-treatment or an improvement from baseline.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=55 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=48 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Cumulative Major Molecular Response (MMR)
MMR
|
82.6 percentage of participants
Interval 68.6 to 92.2
|
76.4 percentage of participants
Interval 63.0 to 86.8
|
56.3 percentage of participants
Interval 41.2 to 70.5
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
—
|
—
|
|
Percentage of Participants With Cumulative Major Molecular Response (MMR)
MR4
|
73.9 percentage of participants
Interval 58.9 to 85.7
|
63.6 percentage of participants
Interval 49.6 to 76.2
|
41.7 percentage of participants
Interval 27.6 to 56.8
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
|
Percentage of Participants With Cumulative Major Molecular Response (MMR)
MR4.5
|
58.7 percentage of participants
Interval 43.2 to 73.0
|
50.9 percentage of participants
Interval 37.1 to 64.6
|
35.4 percentage of participants
Interval 22.2 to 50.5
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 36Population: Evaluable set for cytogenetic response: treated participants with valid baseline cytogenetic assessment (\>= 20 metaphases from baseline bone marrow or CCyR with \>=200 cells from FISH or baseline MMR) and who achieved CCyR. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had CCyR.
Kaplan-Meier analysis. Duration of CCyR: from first date of CCyR to date of confirmed loss of CCyR/disease progression/on-treatment death or censoring, analyzed for responders only. CyR: prevalence of Ph+ cells. CCyR: 0% Ph+ cells from \>=20 metaphases from conventional cytogenetics or \<1% Ph+ cells from \>=200 cells analyzed by FISH or MMR (\<=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory). Confirmed loss: 2 consecutive non-response assessments \>=28 days apart. Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC \>20\*10\^9/L on 2 occasions \>=2 weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=37 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=33 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=3 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 36
|
96.4 percentage of participants
Interval 77.2 to 99.5
|
94.4 percentage of participants
Interval 79.2 to 98.6
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 36Population: Evaluable set for molecular response: treated participants with valid baseline molecular assessment and who achieved MMR. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had MMR.
Kaplan-Meier analysis. Duration of MMR: from first date of MMR to confirmed loss of MMR/disease progression/on-treatment death or censoring, analyzed for responders only. MMR:\<=0.1% BCR-ABL1 on the IS with at least 10,000 ABL1 transcripts assessed by central laboratory . Confirmed loss: 2 consecutive non-response assessments \>=28 days apart with a \<3-log (\>0.1%) reduction in transcripts one of which corresponds to a \<=2-log reduction (\>=1%). Progression: for CP: participants evolving from CP to AP, loss of CHR; loss of MCyR; in participants without CHR WBC \>20\*10\^9/L on 2 occasions \>=2weeks apart after the first 4 weeks of treatment; for AP: confirmed BP, loss of previous hematologic response over a 2-week period, loss of CHR, no decrease from baseline levels (if considered clinically relevant) in percentage blasts in peripheral blood or bone marrow on all assessments over a 4-week period.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=38 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=42 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=27 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=2 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 36
|
90.7 percentage of participants
Interval 73.9 to 96.9
|
81.5 percentage of participants
Interval 63.2 to 91.3
|
90.2 percentage of participants
Interval 65.9 to 97.5
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)Population: The safety analysis set included participants who received at least 1 dose of bosutinib.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE: any event increasing in severity from baseline or any new event started during bosutinib therapy or within 28 days of the last dose of study drug. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 Participants
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
n=163 Participants
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs
TEAEs
|
46 Participants
|
61 Participants
|
48 Participants
|
4 Participants
|
3 Participants
|
162 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs
Treatment-emergent SAEs
|
21 Participants
|
30 Participants
|
14 Participants
|
1 Participants
|
3 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)Population: The safety analysis set included participants who received at least 1 dose of bosutinib.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive 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 AE. Number of participants with Grade 3 or 4 TEAEs are reported.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 Participants
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
n=163 Participants
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
36 Participants
|
49 Participants
|
39 Participants
|
2 Participants
|
3 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)Population: The safety analysis set included participants who received at least 1 dose of bosutinib.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE was any event increasing in severity from baseline or any new event that started during bosutinib therapy or within 28 days of the last dose of study drug. Relatedness to drug was assessed by investigator.
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 Participants
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
n=163 Participants
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Related Treatment Emergent Adverse Events (TEAEs)
|
46 Participants
|
61 Participants
|
48 Participants
|
4 Participants
|
3 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug up to 28 days after last dose (up to maximum of 4 years)Population: The safety analysis set included participants who received at least 1 dose of bosutinib.
Number of participants with any hematological, chemistry and coagulation abnormality of any grade were reported. Hematological: absolute neutrophil count (low), hemoglobin (low), lymphocytes (low), platelets (low) and leukocytes (low). Chemistry: alkaline phosphatase (high), alanine aminotransferase (high), amylase (high), aspartate aminotransferase (high), bilirubin (high), creatinine (high), lipase (high). Coagulation: activated partial prothrombin time (low), prothrombin time (low and high), partial prothrombin time (high).
Outcome measures
| Measure |
Bosutinib, Chronic Phase 2nd and 3rd Line Chronic Myelogenous Leukemia
n=46 Participants
Participants with philadelphia chromosome positive chronic phase 2nd and 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 Participants
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 Participants
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 Participants
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 Participants
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
n=163 Participants
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Hematology
|
38 Participants
|
56 Participants
|
40 Participants
|
4 Participants
|
3 Participants
|
141 Participants
|
|
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Chemistry
|
46 Participants
|
61 Participants
|
49 Participants
|
4 Participants
|
3 Participants
|
163 Participants
|
|
Number of Participants With Laboratory Abnormalities Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Coagulation
|
18 Participants
|
25 Participants
|
12 Participants
|
2 Participants
|
1 Participants
|
58 Participants
|
Adverse Events
Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia
Serious events: 21 serious events
Other events: 46 other events
Deaths: 5 deaths
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
Serious events: 30 serious events
Other events: 61 other events
Deaths: 7 deaths
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
Serious events: 14 serious events
Other events: 48 other events
Deaths: 5 deaths
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Bosutinib: Chronic Myelogenous Leukemia
Serious events: 69 serious events
Other events: 162 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia
n=46 participants at risk
Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 participants at risk
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 participants at risk
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 participants at risk
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 participants at risk
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
n=163 participants at risk
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.8%
3/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Abdominal lymphadenopathy
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Pancytopenia
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cardiac failure
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.7%
6/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Pericardial effusion
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.5%
4/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 unstable
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 complete
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cardiac failure congestive
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cardiogenic shock
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Coronary artery occlusion
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 node dysfunction
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Keratoconus
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.2%
2/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Appendiceal mucocoele
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Colitis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Gastrointestinal haemorrhage
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Hiatus hernia
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Oesophageal fistula
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 polyp
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Subileus
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.5%
4/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Multiple organ dysfunction syndrome
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cholecystitis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cholelithiasis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 cirrhosis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Hypersensitivity
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.2%
2/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Appendicitis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 pneumococcal
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Pseudomembranous colitis
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Sepsis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Arterial restenosis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Hip fracture
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Rib fracture
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Spinal fracture
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Subdural haematoma
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Tendon rupture
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Diabetic ketoacidosis
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Fluid retention
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Metabolic disorder
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.8%
3/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Adenocarcinoma of colon
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Anaplastic large-cell lymphoma
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Brain neoplasm
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Laryngeal squamous cell carcinoma
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Lung neoplasm malignant
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Lymphoma
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Metastases to liver
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Pancreatic carcinoma
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Prostate cancer
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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)
Squamous cell carcinoma of lung
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.8%
3/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cerebrovascular accident
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.2%
2/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Transient ischaemic attack
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.2%
2/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Sciatica
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Anxiety
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.5%
4/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Chronic kidney disease
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Breast mass
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Ovarian cyst ruptured
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
7/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 failure
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.8%
3/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.2%
2/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Acute respiratory failure
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Emphysema
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Hypoxia
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 hypertension
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.8%
3/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 ischaemia
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.2%
2/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Haemorrhage
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Shock haemorrhagic
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.61%
1/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 |
Bosutinib: Chronic Phase 2nd Line Chronic Myelogenous Leukemia
n=46 participants at risk
Participants with philadelphia chromosome positive chronic phase 2nd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 3rd Line Chronic Myelogenous Leukemia
n=61 participants at risk
Participants with philadelphia chromosome positive chronic Phase 3rd line chronic myelogenous leukemia.
|
Bosutinib: Chronic Phase 4th Line Chronic Myelogenous Leukemia
n=49 participants at risk
Participants with philadelphia chromosome positive chronic phase 4th line chronic myelogenous leukemia.
|
Bosutinib: Accelerated Phase Chronic Myelogenous Leukemia
n=4 participants at risk
Participants with philadelphia chromosome positive accelerated phase chronic myelogenous leukemia.
|
Bosutinib: Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
n=3 participants at risk
Participants with BCR-ABL1 positive and philadelphia chromosome negative chronic myelogenous leukemia.
|
Bosutinib: Chronic Myelogenous Leukemia
n=163 participants at risk
Participants with Philadelphia chromosome positive chronic phase 2nd, 3rd and 4th line chronic myelogenous leukemia, Philadelphia chromosome positive accelerated phase chronic myelogenous leukemia and BCR-ABL1-chronic myelogenous leukemia/Philadelphia chromosome negative chronic myelogenous leukemia.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.2%
7/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
23.0%
14/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.2%
5/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
66.7%
2/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.2%
28/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
15.2%
7/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
6/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
4/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
11.7%
19/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.6%
4/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
7/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.7%
6/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Cardiac failure
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.7%
6/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
93.5%
43/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
88.5%
54/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
85.7%
42/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
100.0%
4/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
66.7%
2/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
89.0%
145/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
32.6%
15/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
47.5%
29/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
51.0%
25/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
42.9%
70/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
28.3%
13/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
36.1%
22/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
38.8%
19/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.7%
55/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
30.4%
14/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
27.9%
17/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
32.7%
16/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
50.0%
2/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
30.1%
49/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
41.3%
19/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
13.1%
8/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.4%
9/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
22.7%
37/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
28.3%
13/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.0%
11/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.3%
7/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
19.6%
32/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
6/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.6%
14/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
5/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.7%
11/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
10/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
10.9%
5/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.5%
9/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.7%
6/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
21.7%
10/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
24.6%
15/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
38.8%
19/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
28.2%
46/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
43.5%
20/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.8%
9/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
12.2%
6/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
22.1%
36/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
15.2%
7/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.0%
11/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
26.5%
13/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
19.0%
31/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
19.6%
9/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.0%
11/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.4%
9/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.8%
29/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.7%
6/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.7%
6/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
15.2%
7/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.0%
11/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.3%
8/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
26/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
13.0%
6/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.2%
5/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.6%
14/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
6/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.5%
9/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
8/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
5/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
8/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
13.0%
6/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
7/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.4%
10/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.2%
15/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
21.7%
10/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
29.5%
18/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
32.7%
16/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
27.0%
44/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
19.6%
9/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.0%
11/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
26.5%
13/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.2%
33/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
17.4%
8/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
11.5%
7/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.4%
10/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
26/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
19.6%
9/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.0%
11/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.2%
5/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
15.3%
25/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
10.9%
5/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
13.1%
8/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
16/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
11.5%
7/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
4/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.6%
14/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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-glutamyl transferase increased
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
6/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
13/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 uric acid increased
|
2.2%
1/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
6/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.5%
9/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 folate decreased
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.4%
10/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.3%
7/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.1%
23/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Hyperuricaemia
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
17.4%
8/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
29.5%
18/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
20.4%
10/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
22.7%
37/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
15.2%
7/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
12/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
4/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.1%
23/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
17.4%
8/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
13.1%
8/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.2%
5/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
13.5%
22/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 pain
|
10.9%
5/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.6%
4/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
13/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.6%
4/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
10/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 disorder
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
30.4%
14/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
27.9%
17/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
28.6%
14/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
50.0%
2/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
28.8%
47/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Paraesthesia
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
4/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.7%
11/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
19.6%
9/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
27.9%
17/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
24.5%
12/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
23.9%
39/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
17.4%
8/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
29.5%
18/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.1%
3/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
19.0%
31/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
13.0%
6/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
21.3%
13/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.4%
9/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.8%
29/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
21.7%
10/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.7%
11/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Productive cough
|
0.00%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.6%
4/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.5%
4/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
10.9%
5/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.8%
6/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.3%
7/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
11.0%
18/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
10.9%
5/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
5/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
13/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
10.2%
5/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
50.0%
2/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
13/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
5.5%
9/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
10.9%
5/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.3%
2/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
8/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Acne
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
7/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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 pruritic
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.9%
3/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
7/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.5%
4/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
8.7%
4/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.3%
8/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
25.0%
1/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
9.2%
15/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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%
0/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.6%
4/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.0%
1/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
3.1%
5/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
15.2%
7/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
21.3%
13/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.4%
9/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
17.8%
29/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
4.3%
2/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
8.2%
5/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
4.1%
2/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
66.7%
2/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
6.7%
11/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
17.4%
8/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
14.8%
9/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
18.4%
9/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
33.3%
1/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.6%
27/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
|
19.6%
9/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
13.1%
8/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
16.3%
8/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
15.3%
25/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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
Gastrointestinal disorder
|
6.5%
3/46 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
1.6%
1/61 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/49 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/4 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
0.00%
0/3 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
|
2.5%
4/163 • From first dose of study drug up to 28 days after last dose (up to maximum of 4 years)
The total number of deaths occurring during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 28 days post last study drug dose. Same event may appear as both an AE and Serious Adverse Events. An event may be categorized as serious in 1 participant 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