Trial Outcomes & Findings for A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma (NCT NCT02601950)
NCT ID: NCT02601950
Last Updated: 2025-06-22
Results Overview
ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
267 participants
Primary outcome timeframe
Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)
Results posted on
2025-06-22
Participant Flow
This Phase II, open-label study was conducted at 28 sites in 9 countries (Australia, Belgium, Canada, France, Germany, Italy, Taiwan, United Kingdom, and United States) from 22 December 2015 to 26 February 2024.
Participants were enrolled into 1 of the 8 cohorts based on tumor type. A total of 267 participants were enrolled in the study.
Participant milestones
| Measure |
Rhabdoid Tumors: Cohort 1
Participants with rhabdoid tumors (malignant rhabdoid tumor \[MRT\], rhabdoid tumors of the kidney \[RTK\], atypical teratoid rhabdoid tumor \[ATRT\], and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type \[SCCOHT\], also known as malignant rhabdoid tumor of the ovary \[MRTO\]) received tazemetostat 800 milligram (mg) twice daily (BID) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Synovial Sarcoma: Cohort 2
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
Participants with other integrase interactor 1 (INI-1)-negative tumors or any solid tumor with enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
Participants with renal medullary carcinoma (RMC) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
Participants with epithelioid sarcoma (ES) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
Participants with ES undergoing optional tumor biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
Participants with ES received tazemetostat 1600 mg once daily (QD) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
32
|
14
|
62
|
69
|
18
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
33
|
32
|
14
|
62
|
69
|
18
|
7
|
Reasons for withdrawal
| Measure |
Rhabdoid Tumors: Cohort 1
Participants with rhabdoid tumors (malignant rhabdoid tumor \[MRT\], rhabdoid tumors of the kidney \[RTK\], atypical teratoid rhabdoid tumor \[ATRT\], and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type \[SCCOHT\], also known as malignant rhabdoid tumor of the ovary \[MRTO\]) received tazemetostat 800 milligram (mg) twice daily (BID) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Synovial Sarcoma: Cohort 2
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
Participants with other integrase interactor 1 (INI-1)-negative tumors or any solid tumor with enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
Participants with renal medullary carcinoma (RMC) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
Participants with epithelioid sarcoma (ES) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
Participants with ES undergoing optional tumor biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
Participants with ES received tazemetostat 1600 mg once daily (QD) orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Participant enrolled in rollover study
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Disease progression - radiological
|
21
|
26
|
22
|
11
|
46
|
52
|
7
|
5
|
|
Overall Study
Disease progression - clinical
|
3
|
5
|
4
|
2
|
6
|
6
|
5
|
1
|
|
Overall Study
Death
|
6
|
0
|
3
|
1
|
4
|
1
|
0
|
0
|
|
Overall Study
Unacceptable toxicity (related to study treatment)
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse event (not related to study treatment)
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Participant refused further study treatment
|
0
|
1
|
1
|
0
|
2
|
2
|
2
|
1
|
|
Overall Study
Investigator discretion
|
1
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
0
|
Baseline Characteristics
A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Synovial Sarcoma: Cohort 2
n=33 Participants
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=32 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=14 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=62 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=69 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 16.31 • n=93 Participants
|
38.8 Years
STANDARD_DEVIATION 9.54 • n=4 Participants
|
46.9 Years
STANDARD_DEVIATION 16.94 • n=27 Participants
|
30.7 Years
STANDARD_DEVIATION 10.71 • n=483 Participants
|
37.0 Years
STANDARD_DEVIATION 15.08 • n=36 Participants
|
41.3 Years
STANDARD_DEVIATION 14.00 • n=10 Participants
|
38.9 Years
STANDARD_DEVIATION 17.49 • n=115 Participants
|
40.9 Years
STANDARD_DEVIATION 15.74 • n=40 Participants
|
39.5 Years
STANDARD_DEVIATION 14.89 • n=8 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
26 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
113 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
39 Participants
n=36 Participants
|
43 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
154 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
55 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
231 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
47 Participants
n=36 Participants
|
54 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
200 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
17 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)Population: ITT population included all participants who received at least 1 dose of tazemetostat.
ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=32 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=14 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=62 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=69 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR)
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
16.1 Percentage of participants
Interval 8.0 to 27.7
|
15.9 Percentage of participants
Interval 8.2 to 26.7
|
5.6 Percentage of participants
Interval 0.1 to 27.3
|
—
|
—
|
PRIMARY outcome
Timeframe: At 16 WeeksPopulation: ITT population included all participants who received at least 1 dose of tazemetostat.
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 16 week was estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=33 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat
|
15.2 Percentage of participants
Interval 5.1 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 148 weeksPopulation: Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was medically significant. TEAEs were defined as AEs if one of the following conditions met: emerged after the time of first dose administration, having been absent prior to the first dose; re-emerged, having been present but stopped prior to the time of first dose administration; worsened in severity after the time of first dose administration relative to the pretreatment state, when the AE was continuous.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=7 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)Population: ITT population included all participants who received at least 1 dose of tazemetostat. Only those participants with a confirmed CR or PR (responders) were analyzed.
DOR was defined as time from the first documented evidence of CR or PR based on investigator review to the time of first documented PD or death due to any cause, whichever came first, as per RECIST v 1.1 criteria. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=3 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=3 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=10 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=11 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=1 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=1 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
All Cohorts: Duration of Response (DOR)
|
29.0 Weeks
Interval 24.1 to 32.1
|
—
|
80.1 Weeks
Interval 24.1 to 87.6
|
—
|
88.0 Weeks
Interval 7.1 to 224.4
|
96.1 Weeks
Interval 10.3 to 112.3
|
151.6 Weeks
Interval 151.6 to 151.6
|
119.4 Weeks
Interval 119.4 to 119.4
|
SECONDARY outcome
Timeframe: Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)Population: ITT population included all participants who received at least 1 dose of tazemetostat.
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=33 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=32 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=14 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=62 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=69 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
All Cohorts: Progression-Free Survival (PFS)
|
7.9 Weeks
Interval 7.7 to 15.1
|
8.0 Weeks
Interval 7.6 to 8.1
|
15.7 Weeks
Interval 7.7 to 31.7
|
7.3 Weeks
Interval 6.3 to 15.1
|
23.7 Weeks
Interval 14.7 to 25.7
|
16.1 Weeks
Interval 8.4 to 16.6
|
24.0 Weeks
Interval 6.3 to 175.3
|
39.9 Weeks
Interval 4.1 to
NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.
|
SECONDARY outcome
Timeframe: At Weeks 24, 32 and 56Population: ITT population included all participants who received at least 1 dose of tazemetostat.
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 24, 32 and 56 weeks were estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=33 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=32 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=14 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=62 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=69 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56
Week 24
|
17.6 Percentage of participants
Interval 6.5 to 33.1
|
15.9 Percentage of participants
Interval 5.1 to 32.0
|
34.4 Percentage of participants
Interval 18.2 to 51.2
|
15.4 Percentage of participants
Interval 2.5 to 38.8
|
42.1 Percentage of participants
Interval 29.3 to 54.4
|
33.8 Percentage of participants
Interval 22.9 to 45.0
|
43.6 Percentage of participants
Interval 18.2 to 66.7
|
53.6 Percentage of participants
Interval 13.2 to 82.5
|
|
All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56
Week 32
|
14.1 Percentage of participants
Interval 4.5 to 28.9
|
10.6 Percentage of participants
Interval 2.2 to 26.7
|
26.7 Percentage of participants
Interval 12.3 to 43.5
|
15.4 Percentage of participants
Interval 2.5 to 38.8
|
29.1 Percentage of participants
Interval 17.9 to 41.2
|
29.3 Percentage of participants
Interval 19.1 to 40.4
|
43.6 Percentage of participants
Interval 18.2 to 66.7
|
53.6 Percentage of participants
Interval 13.2 to 82.5
|
|
All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56
Week 56
|
3.5 Percentage of participants
Interval 0.3 to 15.2
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
13.8 Percentage of participants
Interval 3.8 to 29.9
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
21.3 Percentage of participants
Interval 11.6 to 33.0
|
22.6 Percentage of participants
Interval 13.3 to 33.3
|
18.2 Percentage of participants
Interval 1.5 to 50.3
|
26.8 Percentage of participants
Interval 1.3 to 67.0
|
SECONDARY outcome
Timeframe: Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)Population: ITT population included all participants who received at least 1 dose of tazemetostat.
OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=33 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=32 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=14 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=62 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=69 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
All Cohorts: Overall Survival (OS)
|
22.1 Weeks
Interval 14.4 to 54.6
|
43.4 Weeks
Interval 31.7 to 58.1
|
37.9 Weeks
Interval 23.3 to 104.0
|
24.6 Weeks
Interval 8.4 to 73.6
|
82.4 Weeks
Interval 47.4 to 117.0
|
111.4 Weeks
Interval 63.0 to
NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
|
77.7 Weeks
Interval 32.9 to
NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
|
49.6 Weeks
Interval 19.3 to
NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
|
SECONDARY outcome
Timeframe: At Weeks 24, 32 and 56Population: ITT population included all participants who received at least 1 dose of tazemetostat.
OS was defined as the interval of time between the date of the first dose of study treatment and the date of death due to any cause. OS rate at 24, 32 and 56 weeks were estimated. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=33 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=32 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=14 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=62 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=69 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56
Week 24
|
45.4 Percentage of participants
Interval 27.6 to 61.6
|
81.4 Percentage of participants
Interval 63.2 to 91.2
|
68.8 Percentage of participants
Interval 49.7 to 81.8
|
50.0 Percentage of participants
Interval 22.9 to 72.2
|
85.5 Percentage of participants
Interval 73.9 to 92.2
|
83.6 Percentage of participants
Interval 72.3 to 90.6
|
88.9 Percentage of participants
Interval 62.4 to 97.1
|
83.3 Percentage of participants
Interval 27.3 to 97.5
|
|
All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56
Week 32
|
38.6 Percentage of participants
Interval 21.8 to 55.2
|
68.9 Percentage of participants
Interval 49.9 to 81.9
|
56.3 Percentage of participants
Interval 37.6 to 71.3
|
42.9 Percentage of participants
Interval 17.7 to 66.0
|
77.2 Percentage of participants
Interval 64.6 to 85.8
|
75.8 Percentage of participants
Interval 63.6 to 84.4
|
77.8 Percentage of participants
Interval 51.1 to 91.0
|
66.7 Percentage of participants
Interval 19.5 to 90.4
|
|
All Cohorts: Overall Survival (OS) Rate at Weeks 24, 32 and 56
Week 56
|
30.9 Percentage of participants
Interval 15.5 to 47.7
|
37.6 Percentage of participants
Interval 21.3 to 53.8
|
49.6 Percentage of participants
Interval 31.4 to 65.4
|
35.7 Percentage of participants
Interval 13.0 to 59.4
|
57.3 Percentage of participants
Interval 43.9 to 68.6
|
66.5 Percentage of participants
Interval 53.7 to 76.6
|
55.6 Percentage of participants
Interval 30.5 to 74.8
|
44.4 Percentage of participants
Interval 6.6 to 78.5
|
SECONDARY outcome
Timeframe: At Weeks 12, 24, 32 and 48Population: ITT population included all participants who received at least 1 dose of tazemetostat.
DCR was defined as the percentage of participants who achieved a confirmed response (CR or PR, as per RECIST v 1.1 criteria) or who have SD lasting at least 32 weeks from the start of treatment until disease progression or the start of subsequent anti-cancer therapy. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. SD was defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=33 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=32 Participants
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=14 Participants
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=62 Participants
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=69 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 Participants
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 Participants
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48
Week 12
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
15.2 Percentage of participants
Interval 5.1 to 31.9
|
40.6 Percentage of participants
Interval 23.7 to 59.4
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
45.2 Percentage of participants
Interval 32.5 to 58.3
|
36.2 Percentage of participants
Interval 25.0 to 48.7
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
|
All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48
Week 24
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
9.1 Percentage of participants
Interval 1.9 to 24.3
|
21.9 Percentage of participants
Interval 9.3 to 40.0
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
29.0 Percentage of participants
Interval 18.2 to 41.9
|
30.4 Percentage of participants
Interval 19.9 to 42.7
|
33.3 Percentage of participants
Interval 13.3 to 59.0
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
|
All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48
Week 48
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
3.0 Percentage of participants
Interval 0.1 to 15.8
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
24.2 Percentage of participants
Interval 14.2 to 36.7
|
23.2 Percentage of participants
Interval 13.9 to 34.9
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
|
All Cohorts: Disease Control Rate (DCR) at Weeks 12, 24, 32 and 48
Week 32
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
3.0 Percentage of participants
Interval 0.1 to 15.8
|
18.8 Percentage of participants
Interval 7.2 to 36.4
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
25.8 Percentage of participants
Interval 15.5 to 38.5
|
29.0 Percentage of participants
Interval 18.7 to 41.2
|
27.8 Percentage of participants
Interval 9.7 to 53.5
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
SECONDARY outcome
Timeframe: Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)Population: ITT population included all participants who received at least 1 dose of tazemetostat.
ORR was defined as percentage of participants who achieved a confirmed CR or PR based on investigator assessment from start of treatment until PD or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per RANO criteria for primary brain tumors or RECIST v 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
Outcome measures
| Measure |
Rhabdoid Tumors: Cohort 1
n=33 Participants
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-negative: Cohort 3
n=7 Participants
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 2 and 8: Objective Response Rate (ORR)
|
0 Percentage of participants
Interval 0.0 to 10.6
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Rhabdoid Tumors: Cohort 1
Serious events: 18 serious events
Other events: 27 other events
Deaths: 9 deaths
Synovial Sarcoma: Cohort 2
Serious events: 13 serious events
Other events: 28 other events
Deaths: 2 deaths
Other INI1-Negative: Cohort 3
Serious events: 11 serious events
Other events: 29 other events
Deaths: 5 deaths
RMC: Cohort 4
Serious events: 8 serious events
Other events: 12 other events
Deaths: 3 deaths
ES: Cohort 5
Serious events: 25 serious events
Other events: 58 other events
Deaths: 8 deaths
ES Paired Biopsy: Cohort 6
Serious events: 19 serious events
Other events: 65 other events
Deaths: 6 deaths
Chordoma: Cohort 7
Serious events: 7 serious events
Other events: 16 other events
Deaths: 2 deaths
ES 1600 mg: Cohort 8
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 participants at risk
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Synovial Sarcoma: Cohort 2
n=33 participants at risk
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-Negative: Cohort 3
n=32 participants at risk
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=14 participants at risk
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=62 participants at risk
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=69 participants at risk
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 participants at risk
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 participants at risk
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.1%
3/33 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
4.8%
3/62 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
4.3%
3/69 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
2.9%
2/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.1%
3/33 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
2/14 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.1%
1/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Death
|
15.6%
5/32 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
2.9%
2/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Fatigue
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Pyrexia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
2.9%
2/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.2%
2/62 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Infection
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Skin infection
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
4.8%
3/62 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Seizure
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
Platelet count decreased
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Cardiac disorders
Pericardial effusion
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Psychiatric disorders
Confusional state
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/62 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
Other adverse events
| Measure |
Rhabdoid Tumors: Cohort 1
n=32 participants at risk
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Synovial Sarcoma: Cohort 2
n=33 participants at risk
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Other INI1-Negative: Cohort 3
n=32 participants at risk
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
RMC: Cohort 4
n=14 participants at risk
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES: Cohort 5
n=62 participants at risk
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES Paired Biopsy: Cohort 6
n=69 participants at risk
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
Chordoma: Cohort 7
n=18 participants at risk
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
ES 1600 mg: Cohort 8
n=7 participants at risk
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
31.2%
10/32 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
27.3%
9/33 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.1%
9/32 • Number of events 18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
37.1%
23/62 • Number of events 31 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
46.4%
32/69 • Number of events 43 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
44.4%
8/18 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Vomiting
|
40.6%
13/32 • Number of events 18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.1%
9/32 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
35.7%
5/14 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
25.8%
16/62 • Number of events 23 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
13.0%
9/69 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
27.8%
5/18 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Constipation
|
21.9%
7/32 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.1%
4/33 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
15.6%
5/32 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
4/14 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.0%
13/62 • Number of events 17 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.5%
10/69 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
6/32 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.1%
3/33 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
18.8%
6/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.1%
10/62 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
23.2%
16/69 • Number of events 17 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
10.1%
7/69 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Fatigue
|
21.9%
7/32 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
30.3%
10/33 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
34.4%
11/32 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
38.7%
24/62 • Number of events 38 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
30.4%
21/69 • Number of events 26 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
22.2%
4/18 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Asthenia
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.1%
4/33 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
13.0%
9/69 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Oedema peripheral
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
2/14 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.7%
6/62 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
10.1%
7/69 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
General disorders
Pyrexia
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.2%
5/69 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
30.3%
10/33 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.0%
13/62 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.2%
5/69 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.9%
7/32 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
24.2%
8/33 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
4/14 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.7%
6/62 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
10.1%
7/69 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.1%
3/33 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.8%
4/69 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
57.1%
4/7 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
18.8%
6/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.3%
7/62 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.8%
4/69 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
2/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.5%
4/62 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
13.0%
9/69 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.3%
7/62 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
10.1%
7/69 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
15.9%
11/69 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
28.1%
9/32 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
24.2%
8/33 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.9%
7/32 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
2/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
30.6%
19/62 • Number of events 29 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.8%
4/69 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.1%
4/33 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
57.1%
8/14 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
24.2%
15/62 • Number of events 27 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
13.0%
9/69 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.1%
3/33 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.6%
1/62 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.8%
4/69 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
15.2%
5/33 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
17.7%
11/62 • Number of events 17 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.2%
5/69 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Nervous system disorders
Dysgeusia
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
8.1%
5/62 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
1.4%
1/69 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
Weight decreased
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
4/14 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.1%
10/62 • Number of events 22 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
8.7%
6/69 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Investigations
Weight increased
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
9.7%
6/62 • Number of events 17 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
4.3%
3/69 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
4/32 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.1%
4/33 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
4/14 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.1%
10/62 • Number of events 34 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.6%
8/69 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/33 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
8.1%
5/62 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
10.1%
7/69 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
14.3%
2/14 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
8.1%
5/62 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.2%
5/69 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
21.4%
3/14 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
8.1%
5/62 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.8%
4/69 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
12.5%
4/32 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
11.3%
7/62 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.8%
4/69 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
0.00%
0/14 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
4.8%
3/62 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
7.2%
5/69 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER