Trial Outcomes & Findings for MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb (NCT NCT04649359)

NCT ID: NCT04649359

Last Updated: 2025-12-02

Results Overview

ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

187 participants

Primary outcome timeframe

From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)

Results posted on

2025-12-02

Participant Flow

Participants with relapsed/refractory multiple myeloma (RRMM), who were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-cluster of differentiation38 (CD38) monoclonal antibody were included. Study enrolled participants into 2 independent and parallel cohorts: cohort A and B.

A total of 187 participants were enrolled and assigned to study treatment. Results are reported at primary completion date. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at secondary completion date.

Participant milestones

Participant milestones
Measure
Cohort A
Participants who had not previously received a B-cell maturation antigen (BCMA)-directed therapy (BCMA-naïve participants) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W). The initial 4 enrolled participants received subcutaneous elranatamab with a priming regimen of 44 mg on Cycle 1 Day 1 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort B
Participants who had previously received a BCMA-directed therapy (BCMA-exposed) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).
Overall Study
STARTED
123
64
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
123
64

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort A
Participants who had not previously received a B-cell maturation antigen (BCMA)-directed therapy (BCMA-naïve participants) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W). The initial 4 enrolled participants received subcutaneous elranatamab with a priming regimen of 44 mg on Cycle 1 Day 1 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort B
Participants who had previously received a BCMA-directed therapy (BCMA-exposed) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).
Overall Study
Withdrawal by Subject
7
7
Overall Study
Death
41
26
Overall Study
Ongoing in the study
75
31

Baseline Characteristics

MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort A
n=123 Participants
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort B
n=64 Participants
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Total
n=187 Participants
Total of all reporting groups
Age, Continuous
67.1 Years
STANDARD_DEVIATION 9.45 • n=121 Participants
65.7 Years
STANDARD_DEVIATION 9.42 • n=122 Participants
66.6 Years
STANDARD_DEVIATION 9.43 • n=243 Participants
Sex: Female, Male
Female
55 Participants
n=121 Participants
34 Participants
n=122 Participants
89 Participants
n=243 Participants
Sex: Female, Male
Male
68 Participants
n=121 Participants
30 Participants
n=122 Participants
98 Participants
n=243 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants
n=121 Participants
7 Participants
n=122 Participants
18 Participants
n=243 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
85 Participants
n=121 Participants
34 Participants
n=122 Participants
119 Participants
n=243 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
27 Participants
n=121 Participants
23 Participants
n=122 Participants
50 Participants
n=243 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=121 Participants
0 Participants
n=122 Participants
0 Participants
n=243 Participants
Race (NIH/OMB)
Asian
16 Participants
n=121 Participants
1 Participants
n=122 Participants
17 Participants
n=243 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=121 Participants
0 Participants
n=122 Participants
0 Participants
n=243 Participants
Race (NIH/OMB)
Black or African American
9 Participants
n=121 Participants
2 Participants
n=122 Participants
11 Participants
n=243 Participants
Race (NIH/OMB)
White
72 Participants
n=121 Participants
44 Participants
n=122 Participants
116 Participants
n=243 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=121 Participants
0 Participants
n=122 Participants
0 Participants
n=243 Participants
Race (NIH/OMB)
Unknown or Not Reported
26 Participants
n=121 Participants
17 Participants
n=122 Participants
43 Participants
n=243 Participants

PRIMARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)

Population: Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention.

ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

Outcome measures

Outcome measures
Measure
Cohort B
n=64 Participants
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A
n=123 Participants
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
34.4 Percentage of participants
Interval 22.9 to 47.3
61.0 Percentage of participants
Interval 51.8 to 69.6

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)

Population: Safety analysis set included all enrolled participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants with EMD at baseline. This outcome measure was planned only in Cohort A.

ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

Outcome measures

Outcome measures
Measure
Cohort B
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A
n=39 Participants
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline
38.5 Percentage of participants
Interval 23.4 to 55.4

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)

Population: Safety analysis set included all enrolled participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants without EMD at baseline. This outcome measure was planned only in Cohort A.

ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

Outcome measures

Outcome measures
Measure
Cohort B
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A
n=84 Participants
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline
71.4 Percentage of participants
Interval 60.5 to 80.8

SECONDARY outcome

Timeframe: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)

DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)

DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)

DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first documentation of objective sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)

DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)

PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)

PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200mg/24h\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved sFLC levels \[absolute increase \>10mg/dL\]; in participants without measurable serum, urine M-protein levels \& involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status \[absolute increase \>=10%\]; appearance of new lesion,\>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1cm in short axis; \>=50% increase in circulating plasma cells \[\>=200cells/μL\] if this is the only measure of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 20.14 months)

Overall survival (OS) was defined as the time from the date of first dose until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)

Population: Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.

Outcome measures

Outcome measures
Measure
Cohort B
n=22 Participants
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A
n=75 Participants
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Time-to-Response (TTR) as Per IMWG Criteria by BICR
1.92 Months
Interval 0.92 to 6.74
1.22 Months
Interval 0.89 to 7.36

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)

MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment-emergent relative to study intervention if the adverse event start date was during the on-treatment period (i.e. the time from the first dose of study intervention through the minimum of 90 days after last dose, or \[start day of new anticancer therapy - 1 day\]). CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)

CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)

CRS Grade 1: temperature \>=38°C without hypotension or hypoxia; Grade 2: temperature \>=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature \>=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature \>=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure \[CPAP\], bilevel positive airway pressure \[BiPAP\], intubation and mechanical ventilation); Grade 5: death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)

ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (\>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycle 4 and Pre-dose on Day 1 of Cycle 7

Population: The pharmacokinetic (PK) analysis set was a subset of safety analysis set and included participants who had at least one post dose concentration measurement. Here, "Overall Number of Participants Analyzed" signifies maximum participants evaluable for this outcome measure.

Total and free concentrations of Elranatamab on Cycle 4 Day 1 (C4D1) and Cycle 7 Day 1 (C7D1) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Cohort B
n=21 Participants
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort A
n=38 Participants
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Serum Concentration of Elranatamab
Free elranatamab concentrations (C7D1)
29880 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
32830 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 81
Serum Concentration of Elranatamab
Free elranatamab concentrations (C4D1)
16170 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 114
19090 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 89
Serum Concentration of Elranatamab
Total elranatamab concentrations (C4D1)
22840 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 63
31100 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
Serum Concentration of Elranatamab
Total elranatamab concentrations (C7D1)
29880 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 77
37960 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47

SECONDARY outcome

Timeframe: From the date of first dose up to 20.14 months

Outcome measures

Outcome data not reported

Adverse Events

Cohort A

Serious events: 84 serious events
Other events: 123 other events
Deaths: 43 deaths

Cohort B

Serious events: 44 serious events
Other events: 63 other events
Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure
Cohort A
n=123 participants at risk
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort B
n=64 participants at risk
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Blood and lymphatic system disorders
Anemia
4.1%
5/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
4.7%
3/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Aplasia pure red cell
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Febrile neutropenia
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Neutropenia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Thrombocytopenia
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Angina pectoris
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Atrial fibrillation
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Cardiac failure acute
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Cardio-respiratory arrest
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Cardiogenic shock
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Cardiopulmonary failure
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Sinus bradycardia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Sinus tachycardia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Ear and labyrinth disorders
Vertigo
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Eye disorders
Blindness
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Eye disorders
Retinal detachment
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Eye disorders
Visual impairment
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Constipation
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Diarrhoea
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Diarrhoea haemorrhagic
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Hiatus hernia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Oesophagitis
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Vomiting
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Asthenia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Disease progression
4.9%
6/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
General physical health deterioration
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Inflammation
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Injection site reaction
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Mucosal inflammation
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Non-cardiac chest pain
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Oedema peripheral
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Pyrexia
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Hepatobiliary disorders
Hepatitis fulminant
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Immune system disorders
Cytokine release syndrome
13.0%
16/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
10.9%
7/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Immune system disorders
Hypogammaglobulinaemia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Abscess limb
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Adenovirus infection
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Appendicitis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Aspergilloma
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Bacteraemia
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Bronchitis
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Bronchitis viral
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
COVID-19
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
COVID-19 pneumonia
12.2%
15/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
10.9%
7/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Cellulitis
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Chronic sinusitis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Clostridium difficile infection
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Cytomegalovirus infection reactivation
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Device related bacteraemia
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Device related sepsis
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Enterocolitis infectious
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Escherichia sepsis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Escherichia urinary tract infection
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Herpes virus infection
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Histoplasmosis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Klebsiella sepsis
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Lower respiratory tract infection viral
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Parvovirus B19 infection
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumocystis jirovecii pneumonia
4.9%
6/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia
7.3%
9/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
4.7%
3/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia adenoviral
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia bacterial
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia cytomegaloviral
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia fungal
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia influenzal
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia pseudomonal
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia viral
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Post-acute COVID-19 syndrome
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pseudomonal sepsis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pyelonephritis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pyelonephritis acute
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Rhinovirus infection
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Sepsis
4.1%
5/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Septic shock
3.3%
4/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Sinusitis
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Skin infection
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Staphylococcal bacteraemia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Staphylococcal sepsis
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Streptococcal sepsis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Urinary tract infection
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Urinary tract infection bacterial
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Urosepsis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Viral infection
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Viral upper respiratory tract infection
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Injury, poisoning and procedural complications
Fall
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Injury, poisoning and procedural complications
Humerus fracture
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Injury, poisoning and procedural complications
Procedural pneumothorax
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Injury, poisoning and procedural complications
Upper limb fracture
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Blood creatinine increased
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Parvovirus B19 test positive
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
SARS-CoV-2 antibody test positive
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
SARS-CoV-2 test positive
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Weight decreased
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Decreased appetite
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Dehydration
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Failure to thrive
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypokalaemia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Tumor lysis syndrome
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Arthralgia
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Bone pain
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Myositis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Polyarthritis
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Sarcopenia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma refractory
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Altered state of consciousness
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Ataxia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Depressed level of consciousness
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Guillain-Barre syndrome
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Metabolic encephalopathy
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Syncope
2.4%
3/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Toxic encephalopathy
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Trigeminal neuralgia
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Psychiatric disorders
Confusional state
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Psychiatric disorders
Mental status changes
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Renal and urinary disorders
Acute kidney injury
3.3%
4/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Renal and urinary disorders
Renal failure
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Cough
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.81%
1/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
1.6%
2/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Vascular disorders
Hypertension
0.00%
0/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.

Other adverse events

Other adverse events
Measure
Cohort A
n=123 participants at risk
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Cohort B
n=64 participants at risk
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Blood and lymphatic system disorders
Anaemia
47.2%
58/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
60.9%
39/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Leukopenia
13.8%
17/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
18.8%
12/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Lymphopenia
26.0%
32/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
34.4%
22/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Neutropenia
48.0%
59/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
37.5%
24/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Blood and lymphatic system disorders
Thrombocytopenia
29.3%
36/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
42.2%
27/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Sinus tachycardia
4.9%
6/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Cardiac disorders
Tachycardia
5.7%
7/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Abdominal pain
4.9%
6/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Constipation
13.0%
16/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
17.2%
11/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Diarrhoea
38.2%
47/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
28.1%
18/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Dry mouth
4.9%
6/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Nausea
26.0%
32/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Gastrointestinal disorders
Vomiting
15.4%
19/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
12.5%
8/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Asthenia
17.9%
22/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
15.6%
10/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Chills
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Fatigue
34.1%
42/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Injection site erythema
7.3%
9/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Injection site reaction
26.0%
32/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
12.5%
8/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Oedema peripheral
13.8%
17/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
4.7%
3/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Pain
4.1%
5/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
General disorders
Pyrexia
22.0%
27/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
17.2%
11/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Immune system disorders
Cytokine release syndrome
52.0%
64/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
53.1%
34/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Immune system disorders
Hypogammaglobulinaemia
8.9%
11/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Pneumonia
5.7%
7/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Sinusitis
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Upper respiratory tract infection
17.9%
22/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
10.9%
7/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Infections and infestations
Urinary tract infection
6.5%
8/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Injury, poisoning and procedural complications
Fall
11.4%
14/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Alanine aminotransferase increased
13.0%
16/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Aspartate aminotransferase increased
14.6%
18/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
10.9%
7/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Blood alkaline phosphatase increased
6.5%
8/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Blood creatinine increased
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Blood lactate dehydrogenase increased
5.7%
7/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
SARS-CoV-2 test positive
22.0%
27/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Investigations
Weight decreased
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
4.7%
3/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Decreased appetite
32.5%
40/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
17.2%
11/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypercalcaemia
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hyperglycaemia
4.1%
5/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypoalbuminaemia
3.3%
4/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
12.5%
8/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypocalcaemia
5.7%
7/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
12.5%
8/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypokalaemia
22.8%
28/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
17.2%
11/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypomagnesaemia
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hyponatraemia
8.9%
11/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Metabolism and nutrition disorders
Hypophosphataemia
5.7%
7/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Arthralgia
14.6%
18/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
12.5%
8/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Back pain
12.2%
15/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Bone pain
4.9%
6/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
15.6%
10/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Muscle spasms
7.3%
9/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
4.7%
3/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Myalgia
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
1.6%
1/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Musculoskeletal and connective tissue disorders
Pain in extremity
7.3%
9/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
17.2%
11/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Dizziness
10.6%
13/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
3.1%
2/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Nervous system disorders
Headache
22.0%
27/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
10.9%
7/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Psychiatric disorders
Insomnia
13.0%
16/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
12.5%
8/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Cough
22.0%
27/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
17.2%
11/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
14.1%
9/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Respiratory, thoracic and mediastinal disorders
Productive cough
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
0.00%
0/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Skin and subcutaneous tissue disorders
Dry skin
16.3%
20/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Skin and subcutaneous tissue disorders
Erythema
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Skin and subcutaneous tissue disorders
Pruritus
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Skin and subcutaneous tissue disorders
Rash
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
6.2%
4/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Skin and subcutaneous tissue disorders
Rash maculo-papular
7.3%
9/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Skin and subcutaneous tissue disorders
Skin exfoliation
10.6%
13/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
9.4%
6/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Vascular disorders
Hypertension
8.1%
10/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
4.7%
3/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
Vascular disorders
Hypotension
9.8%
12/123 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
7.8%
5/64 • From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

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 publication 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