Trial Outcomes & Findings for Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer (NCT NCT03043313)
NCT ID: NCT03043313
Last Updated: 2024-11-26
Results Overview
cORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to less than (\<)1.0 centimeter (cm). PR was defined as at least a 30 percentage (%) decrease in post-baseline sum of the diameters (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline sum of diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
117 participants
Primary outcome timeframe
Up to 46.6 months
Results posted on
2024-11-26
Participant Flow
A total of 117 participants were enrolled at a total of 56 sites in the United States, Italy, France, Belgium, and Spain. The date of first participant enrollment was 23-Jun-2017. The date of last participant randomization was 02-Nov-2023.
Participant milestones
| Measure |
Tucatinib+Trastuzumab (Cohort A)
Non-randomized cohort. Participants received Tucatinib 300 milligrams (mg) orally (PO) twice daily (BID) on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 milligram/kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until progressive disease (PD), death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib+Trastuzumab (Cohort B)
Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Monotherapy (Cohort C)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using response evaluation criteria in solid tumors \[RECIST\] version \[v\] 1.1), or if they had not achieved a partial response (PR) or complete response (CR) by the week 12 assessment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
41
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
41
|
31
|
Reasons for withdrawal
| Measure |
Tucatinib+Trastuzumab (Cohort A)
Non-randomized cohort. Participants received Tucatinib 300 milligrams (mg) orally (PO) twice daily (BID) on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 milligram/kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until progressive disease (PD), death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib+Trastuzumab (Cohort B)
Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Monotherapy (Cohort C)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using response evaluation criteria in solid tumors \[RECIST\] version \[v\] 1.1), or if they had not achieved a partial response (PR) or complete response (CR) by the week 12 assessment.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Death
|
28
|
26
|
17
|
|
Overall Study
Participation terminated by sponsor
|
11
|
13
|
13
|
Baseline Characteristics
Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Tucatinib+Trastuzumab (Cohort A)
n=45 Participants
Non-randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib+Trastuzumab (Cohort B)
n=39 Participants
Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Monotherapy (Cohort C)
n=30 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 Years
n=99 Participants
|
57 Years
n=107 Participants
|
59.5 Years
n=206 Participants
|
56 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
89 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
20 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
North America
|
45 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
|
Region of Enrollment
Europe
|
0 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 46.6 monthsPopulation: The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in the statistical analysis plan (SAP).
cORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to less than (\<)1.0 centimeter (cm). PR was defined as at least a 30 percentage (%) decrease in post-baseline sum of the diameters (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=84 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Confirmed Objective Response Rate (cORR) Per RECIST v1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B
|
39.3 Percentage of Participants
Interval 28.8 to 50.5
|
—
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in SAP.
ORR per BICR by 12 Weeks was defined as the percentage of participants with CR or PR by 12 weeks of treatment, and before time of crossover (Cohort C), whichever came earlier. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to more than \<1.0 cm. PR was defined as at least a 30% decrease in post-baseline sum of the diameters (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline sum of diameter.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=84 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=30 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
ORR by 12 Weeks of Treatment Per RECIST v1.1 According to BICR Assessment
|
28.6 Percentage of Participants
Interval 19.2 to 39.5
|
3.3 Percentage of Participants
Interval 0.1 to 17.2
|
SECONDARY outcome
Timeframe: Up to 64.1 monthsPopulation: The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants who had CR or PR.
DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to more than \<1.0 cm. PR was defined as at least a 30% decrease in post-baseline sum of the diameters (PBSD) (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. PD was defined as: at least one new malignant lesion, which also includes any lymph node that was normal at baseline (\<1.0 cm short axis) and increased to more than or equal to (\>=)1.0 cm short axis during follow-up or at least a 20% increase in PBSD taking as reference the minimum sum of the diameters (MSD). In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=33 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=30 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Duration of Response (DOR) Per RECIST v1.1 According to BICR Assessment
|
15.2 Months
Interval 8.9 to 20.5
|
NA Months
Data for median and lower or upper limits could not be estimated due to insufficient participants with event.
|
SECONDARY outcome
Timeframe: Up to 64.1 monthsPopulation: The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in SAP.
PFS was defined as the time from start of study treatment (Cohort A) or date of randomization (Cohort B) to documented disease progression (as determined by BICR per RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as: at least one new malignant lesion, which also included any lymph node that was normal at baseline (\<1.0 cm short axis) and increased to \>=1.0 cm short axis during follow-up or at least a 20% increase in post-baseline sum of the diameters (PBSD) taking as reference the minimum sum of the diameters (MSD). In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=84 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Progression-Free Survival (PFS) Per RECIST v1.1 According to BICR Assessment for Pooled Cohorts A+B
|
8.1 Months
Interval 4.2 to 10.2
|
—
|
SECONDARY outcome
Timeframe: Up to 71.8 monthsPopulation: The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had HER2+ tumors as defined by one or more protocol required local tests. Data for cohort A and B was combined as prespecified in SAP.
OS was defined as the time from start of study treatment (Cohort A) or randomization (Cohort B) to date of death due to any cause.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=84 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Overall Survival (OS) in Pooled Cohorts A+B
|
23.9 Months
Interval 18.7 to 28.3
|
—
|
SECONDARY outcome
Timeframe: Up to 49.3 monthsPopulation: The safety analysis set included participants who received any amount of study treatment. Data for cohort A and B was combined as prespecified in SAP.
AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up through 30 days after the last dose of study treatment (tucatinib or trastuzumab). Serious AE (SAE): An event that at any dose led to death; life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Relatedness was judged by investigator According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G) 3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=30 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Any TEAE
|
82 Participants
|
28 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Tucatinib-related TEAE
|
63 Participants
|
22 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Trastuzumab-related TEAE
|
58 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Any grade 3-5 TEAE
|
33 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Trastuzumab-related grade 3-5 TEAE
|
6 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Tucatinib-related grade 3-5 TEAE
|
8 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Any Treatment-Emergent Serious AE (TESAE)
|
19 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Tucatinib-related TESAE
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Trastuzumab-related TESAE
|
2 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
TEAE leading to death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Discontinuation of any study treatment due to TEAE
|
5 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Discontinuation of tucatinib due to TEAE
|
5 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Discontinuation of tucatinib due to tucatinib-related TEAE
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Discontinuation of trastuzumab due to TEAE
|
3 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
|
Number of Participants With Adverse Events (AEs): Interim Analysis
Discontinuation of trastuzumab due to trastuzumab-related TEAE
|
0 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
SECONDARY outcome
Timeframe: Up to 65.1 monthsPopulation: The safety analysis set included participants who received any amount of study treatment. Data for cohort A and B was combined as prespecified in SAP.
AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up through 30 days after the last dose of study treatment (tucatinib or trastuzumab). SAE: An event that at any dose led to death; life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Relatedness was judged by investigator According to NCI CTCAE version 4.03: Grade(G) 3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=28 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With AEs: Final Analysis
Any Treatment-Emergent Serious AE (TESAE)
|
20 Participants
|
6 Participants
|
|
Number of Participants With AEs: Final Analysis
Any TEAE
|
82 Participants
|
23 Participants
|
|
Number of Participants With AEs: Final Analysis
Tucatinib-related TEAE
|
64 Participants
|
15 Participants
|
|
Number of Participants With AEs: Final Analysis
Trastuzumab-related TEAE
|
59 Participants
|
13 Participants
|
|
Number of Participants With AEs: Final Analysis
More than or equal to (>=) Grade 3 TEAE
|
35 Participants
|
9 Participants
|
|
Number of Participants With AEs: Final Analysis
Tucatinib-related >= grade 3 TEAE
|
8 Participants
|
2 Participants
|
|
Number of Participants With AEs: Final Analysis
Trastuzumab-related >= grade 3 TEAE
|
6 Participants
|
2 Participants
|
|
Number of Participants With AEs: Final Analysis
Tucatinib-related TESAE
|
3 Participants
|
0 Participants
|
|
Number of Participants With AEs: Final Analysis
Trastuzumab-related TESAE
|
2 Participants
|
2 Participants
|
|
Number of Participants With AEs: Final Analysis
TEAE leading to death
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs: Final Analysis
Discontinuation of any study treatment due to TEAE
|
5 Participants
|
2 Participants
|
|
Number of Participants With AEs: Final Analysis
Discontinuation of tucatinib due to treatment-related TEAE
|
2 Participants
|
2 Participants
|
|
Number of Participants With AEs: Final Analysis
Discontinuation of tucatinib due to tucatinib-related TEAE
|
2 Participants
|
2 Participants
|
|
Number of Participants With AEs: Final Analysis
Discontinuation of trastuzumab due to treatment-related TEAE
|
1 Participants
|
1 Participants
|
|
Number of Participants With AEs: Final Analysis
Discontinuation of trastuzumab due to trastuzumab-related TEAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 49.3 monthsPopulation: The safety analysis set included participants who received any amount of study treatment. Data for cohort A and B was combined as prespecified in SAP.
Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being held for a TEAE, it was discontinued.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=30 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis
Tucatinib dose held
|
20 Participants
|
3 Participants
|
|
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis
Tucatinib dose reduced
|
8 Participants
|
1 Participants
|
|
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis
Trastuzumab dose held
|
24 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
|
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis
Trastuzumab infusion interrupted (received full dose within 24 hrs)
|
6 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
|
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis
Trastuzumab infusion stopped early (full dose not received)
|
1 Participants
|
NA Participants
Tucatinib monotherapy arm.
|
SECONDARY outcome
Timeframe: Up to 65.1 monthsPopulation: The safety analysis set included participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.
Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being held for a TEAE, it was discontinued. Drug interruption included infusion interrupted (full dose received within 24hrs).
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=28 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With AEs Resulting in Dose Modification: Final Analysis
Tucatinib dose held
|
23 Participants
|
7 Participants
|
|
Number of Participants With AEs Resulting in Dose Modification: Final Analysis
Tucatinib dose reduced
|
9 Participants
|
2 Participants
|
|
Number of Participants With AEs Resulting in Dose Modification: Final Analysis
Trastuzumab dose held
|
27 Participants
|
2 Participants
|
|
Number of Participants With AEs Resulting in Dose Modification: Final Analysis
Trastuzumab infusion interrupted
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 49.3 monthsPopulation: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The following hematology laboratory parameters were assessed: Hemoglobin decreased; leukocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v4.03 was used for the lab parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=85 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=29 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Hemoglobin decreased, Grade 1
|
28 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Hemoglobin decreased, Grade 2
|
8 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Hemoglobin decreased, Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Hemoglobin decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Leukocytes decreased, Grade 1
|
14 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Leukocytes decreased, Grade 2
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Leukocytes decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Leukocytes decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Neutrophils decreased, Grade 1
|
6 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Neutrophils decreased, Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Neutrophils decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Neutrophils decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Platelets decreased, Grade 1
|
11 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Platelets decreased, Grade 2
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Platelets decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Platelets decreased, Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 65.1 monthsPopulation: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The following hematology laboratory parameters were assessed: Hemoglobin decreased; hemoglobin increased; leukocytes decreased; lymphocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v4.03 was used for the lab parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=85 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=28 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Hemoglobin decreased, All grades
|
42 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Hemoglobin decreased, Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Hemoglobin decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Hemoglobin increased: All grades
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Hemoglobin increased: Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Hemoglobin increased: Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Leukocytes decreased, All grades
|
21 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Leukocytes decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Leukocytes decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Lymphocytes decreased, All grades
|
25 Participants
|
11 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Lymphocytes decreased, Grade 3
|
6 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Lymphocytes decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Neutrophils decreased: All grades
|
10 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Neutrophils decreased: Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Neutrophils decreased: Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Platelets decreased, All grades
|
15 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Platelets decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis
Platelets decreased, Grade 4
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 49.3 monthsPopulation: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v5.0 was used for creatinine increased. NCI CTCAE v4.03 was used for the other laboratory parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=85 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=29 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium increased, Grade 1
|
5 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium increased, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium increased, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium decreased, Grade 1
|
13 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium decreased, Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium decreased, Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Potassium decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Aspartate Aminotransferase increased, Grade 1
|
20 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Aspartate Aminotransferase increased, Grade 2
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Aspartate Aminotransferase increased, Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Aspartate Aminotransferase increased, Grade 4
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alanine Aminotransferase increased, Grade 1
|
31 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alanine Aminotransferase increased, Grade 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alanine Aminotransferase increased, Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alanine Aminotransferase increased, Grade 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Creatinine increased, Grade 1
|
38 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Creatinine increased, Grade 2
|
11 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Creatinine increased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Creatinine increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alkaline Phosphatase increased, Grade 1
|
16 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alkaline Phosphatase increased, Grade 2
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alkaline Phosphatase increased, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Alkaline Phosphatase increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Total Bilirubin increased, Grade 1
|
14 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Total Bilirubin increased, Grade 2
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Total Bilirubin increased, Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis
Total Bilirubin increased, Grade 4
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 65.1 monthsPopulation: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number evaluable for specified rows.
The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased; albumin decreased; calcium corrected for albumin decreased; calcium corrected for albumin increased; glomerular filtration rate (GFR), estimated decreased; glucose decreased; glucose increased; sodium decreased; sodium increased; calcium and ionized increased. Treatment emergent laboratory abnormalities: Abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v5.0 used for creatinine increased. NCI CTCAE v4.03 used for the other laboratory parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=85 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=28 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Potassium increased, All grades
|
6 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Potassium increased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Potassium increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Potassium decreased, All grades
|
15 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Potassium decreased, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Potassium decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Aspartate Aminotransferase increased, All grades
|
29 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Aspartate Aminotransferase increased, Grade 3
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Aspartate Aminotransferase increased, Grade 4
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Alanine Aminotransferase increased, All grades
|
39 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Alanine Aminotransferase increased, Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Alanine Aminotransferase increased, Grade 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Creatinine increased, All grades
|
50 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Creatinine increased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Creatinine increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Alkaline Phosphatase increased, All grades
|
21 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Alkaline Phosphatase increased, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Alkaline Phosphatase increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Total Bilirubin increased, All grades
|
25 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Total Bilirubin increased, Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Total Bilirubin increased, Grade 4
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Albumin decreased, All grades
|
23 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Albumin decreased, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Albumin decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium Corrected for Albumin decreased, All grades
|
11 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium Corrected for Albumin decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium Corrected for Albumin decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium Corrected for Albumin increased, All grades
|
8 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium Corrected for Albumin increased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium Corrected for Albumin increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glomerular Filtration Rate, Estimated decreased, All grades
|
51 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glomerular Filtration Rate, Estimated decreased, Grade 3
|
6 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glomerular Filtration Rate, Estimated decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glucose decreased, All grades
|
10 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glucose decreased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glucose decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glucose increased, All grades
|
48 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glucose increased, Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Glucose increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Sodium decreased, All grades
|
18 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Sodium decreased, Grade 3
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Sodium decreased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Sodium increased, All grades
|
7 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Sodium increased, Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Sodium increased, Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium, Ionized increased: All grades
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium, Ionized increased: Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Calcium, Ionized increased: Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 65.1 monthsPopulation: The safety analysis set included participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP.
Vital signs included temperature, oxygen saturation, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and weight. Vital signs were considered clinically significant: temperature: \>= 38 degree Celsius (C); oxygen saturation less than (\<)88%; SBP \>=120 millimeters of mercury (mmHg) or DBP \>=80 mmHg; SBP \>=140 mmHg or DBP \>=90 mmHg; SBP \>=160 mmHg or DBP \>=100 mmHg and heart rate \>100 beats per minute (bpm) and maximum decrease from baseline in weight in kilograms (kg).
Outcome measures
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=28 Participants
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
Temperature >=38 degree C
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
Oxygen saturation <88%
|
8 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
SBP >= 120 mmHg or DBP >= 80 mmHg
|
80 Participants
|
27 Participants
|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
SBP >= 140 mmHg or DBP >= 90 mmHg
|
49 Participants
|
13 Participants
|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
SBP >= 160 mmHg or DBP >= 100 mmHg
|
21 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
Heart rate > 100 bpm
|
26 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Vital Signs: Final Analysis
Maximum decrease from baseline in weight (kg)
|
65 Participants
|
23 Participants
|
Adverse Events
Tucatinib+Trastuzumab (Cohorts A+B)
Serious events: 20 serious events
Other events: 82 other events
Deaths: 54 deaths
Tucatinib Pre-Crossover (Cohort C)
Serious events: 3 serious events
Other events: 28 other events
Deaths: 2 deaths
Tucatinib Post-Crossover (Cohort C)
Serious events: 6 serious events
Other events: 23 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 participants at risk
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=30 participants at risk
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
Tucatinib Post-Crossover (Cohort C)
n=28 participants at risk
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal perforation
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Anorectal infection
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Kidney infection
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Tucatinib+Trastuzumab (Cohorts A+B)
n=86 participants at risk
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
Tucatinib Pre-Crossover (Cohort C)
n=30 participants at risk
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
|
Tucatinib Post-Crossover (Cohort C)
n=28 participants at risk
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pelvic pain
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
9/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
11/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
20.0%
6/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
6/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
14.0%
12/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
13.3%
4/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.3%
57/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
33.3%
10/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
39.3%
11/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.7%
29/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
16.7%
5/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.3%
14/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
14.3%
4/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
16.7%
5/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
18.6%
16/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
43.0%
37/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
20.0%
6/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
20.9%
18/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
21.4%
6/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
7.0%
6/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
13.3%
4/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
14.3%
4/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.9%
18/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
14.3%
4/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
9.3%
8/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.8%
17/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
13.3%
4/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.6%
16/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
14.3%
4/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.6%
16/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
21.4%
6/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.8%
11/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.3%
8/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
9/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.0%
3/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
10.5%
9/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
15/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
14.3%
4/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.0%
12/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.3%
8/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.0%
6/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.8%
5/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
7.0%
6/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
19.8%
17/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.3%
8/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
7.1%
2/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
9/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
10.7%
3/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.1%
7/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
6.7%
2/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
17.4%
15/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Eye disorders
Blepharospasm
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Nail infection
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Rash pustular
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.5%
3/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.3%
1/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
1/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
2.3%
2/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
3.6%
1/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
4.7%
4/86 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/30 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
0.00%
0/28 • All-cause mortality: From start of study treatment to death by any cause (maximum up to 71.8 months); adverse events were followed during the safety reporting period (from Day 1 through 30 days after the last dose of study treatment) maximum up to 65.1 months
Adverse events (AEs) for Cohorts A and B were analyzed together as prespecified in SAP. All-Cause Mortality is reported for all enrolled participants, regardless of whether or not they received study drug. SAEs and non-serious AEs are reported only for those participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place