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Trial Outcomes & Findings for A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma (NCT NCT03677141)

NCT ID: NCT03677141

Last Updated: 2024-12-18

Results Overview

The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

117 participants

Primary outcome timeframe

6-8 weeks after either C6D1 or last dose of study treatment

Results posted on

2024-12-18

Participant Flow

Participant milestones

Participant milestones
Measure
Group A1: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Overall Study
STARTED
3
4
8
40
40
22
Overall Study
COMPLETED
1
3
1
28
31
19
Overall Study
NOT COMPLETED
2
1
7
12
9
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Group A1: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Group A2: Phase Ib Mosunetuzumab + CHOP
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Overall Study
Death
2
1
6
9
5
3
Overall Study
Lost to Follow-up
0
0
0
2
0
0
Overall Study
Screen failure or enrolled in error
0
0
0
0
2
0
Overall Study
Physician Decision
0
0
0
0
1
0
Overall Study
Withdrawal by Subject
0
0
1
1
1
0

Baseline Characteristics

A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group A1: Phase Ib Mosunetuzumab + CHOP
n=3 Participants
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Group A2: Phase Ib Mosunetuzumab + CHOP
n=4 Participants
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
Group B: Phase Ib Mosunetuzumab + CHP-Pola
n=8 Participants
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
n=40 Participants
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Total
n=117 Participants
Total of all reporting groups
Age, Continuous
72.0 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
71.3 Years
STANDARD_DEVIATION 3.4 • n=7 Participants
60.1 Years
STANDARD_DEVIATION 18.0 • n=5 Participants
63.4 Years
STANDARD_DEVIATION 11.0 • n=4 Participants
65.0 Years
STANDARD_DEVIATION 10.0 • n=21 Participants
57.7 Years
STANDARD_DEVIATION 14.3 • n=8 Participants
63.2 Years
STANDARD_DEVIATION 12.1 • n=8 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
18 Participants
n=4 Participants
14 Participants
n=21 Participants
8 Participants
n=8 Participants
44 Participants
n=8 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
22 Participants
n=4 Participants
26 Participants
n=21 Participants
14 Participants
n=8 Participants
73 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
3 Participants
n=8 Participants
12 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
36 Participants
n=4 Participants
35 Participants
n=21 Participants
18 Participants
n=8 Participants
100 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
3 Participants
n=21 Participants
1 Participants
n=8 Participants
5 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
10 Participants
n=4 Participants
5 Participants
n=21 Participants
0 Participants
n=8 Participants
15 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
28 Participants
n=4 Participants
30 Participants
n=21 Participants
20 Participants
n=8 Participants
93 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
4 Participants
n=21 Participants
1 Participants
n=8 Participants
7 Participants
n=8 Participants

PRIMARY outcome

Timeframe: 6-8 weeks after either C6D1 or last dose of study treatment

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. The primary efficacy analysis compared Arm 1 vs Arm 2, with participants grouped according to the treatment arm assigned at randomization. Group C was included in secondary efficacy analysis, and efficacy analyses for Arms A1, A2, and B were exploratory.

The CR rate was defined as the percentage of participants with CR. Assessments were made according to the Lugano 2014 Response Criteria.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC)
72.5 Percentage of participants
Interval 56.11 to 85.4
77.3 Percentage of participants
Interval 54.63 to 92.18
—
—
—

SECONDARY outcome

Timeframe: 6-8 weeks after C6D1 or last dose of study treatment

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
CR Rate at PRA Based on CT Only as Determined by the Investigator (Phase II)
50.0 Percentage of participants
Interval 33.8 to 66.2
47.5 Percentage of participants
Interval 31.51 to 63.87
31.8 Percentage of participants
Interval 13.86 to 54.87
—
—

SECONDARY outcome

Timeframe: 6-8 weeks after C6D1 or last dose of study treatment

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.

ORR is defined as a CR or PR at the time of primary assessment based on PET-CT, as determined by the investigator.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Overall Response Rate (ORR) at PRA Based on PET-CT as Determined by the Investigator (Phase II)
87.5 Percentage of participants
Interval 73.2 to 95.81
80.0 Percentage of participants
Interval 64.35 to 90.95
77.3 Percentage of participants
Interval 54.63 to 92.18
—
—

SECONDARY outcome

Timeframe: 6-8 weeks after C6D1 or last dose of study treatment

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.

ORR is defined as a CR or PR at the time of primary assessment based on CT only, as determined by the investigator.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
ORR at PRA Based on CT Only as Determined by the Investigator (Phase II)
85.0 Percentage of participants
Interval 70.16 to 94.29
72.5 Percentage of participants
Interval 56.11 to 85.4
81.8 Percentage of participants
Interval 59.72 to 94.81
—
—

SECONDARY outcome

Timeframe: Up to approximately 50 months

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory.

Best ORR was defined as CR or PR at any time on study and based on PET-CT or CT only as determined by the investigator.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=36 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Best ORR Based on PET-CT and/or CT Scan as Determined by the Investigator (Phase II)
95.0 Percentage of responders
Interval 83.08 to 99.39
85.0 Percentage of responders
Interval 70.16 to 94.29
95.5 Percentage of responders
Interval 77.16 to 99.88
—
—

SECONDARY outcome

Timeframe: Up to approximately 50 months

Population: The number of participants analyzed was the number of participants with a PR or CR in each arm. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment). Efficacy analyses for Arms A1, A2, and B were exploratory.

DOR is defined as the time from the first occurrence of a documented objective response to disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment).

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=38 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=34 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=21 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Duration of Response (DOR) as Determined by the Investigator (Phase II)
NA Months
Interval 0.0 to 28.0
This value could not be determined due to an insufficient number of participants with the event.
NA Months
Interval 0.0 to 28.0
This value could not be determined due to an insufficient number of participants with the event.
NA Months
Interval 1.0 to 27.0
This value could not be determined due to an insufficient number of participants with the event.
—
—

SECONDARY outcome

Timeframe: Up to approximately 50 months

Population: Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day).

PFS is defined as the time from randomization to the first occurrence of disease progression or relapse as determined by the investigator, or death from any cause, whichever occurs first. The earliest contributing event to PFS is reported. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment were censored at the date of randomization or first study treatment, plus 1 day).

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Progression-free Survival (PFS) as Determined by the Investigator (Phase II)
NA Months
Interval 0.0 to 31.0
This value could not be determined due to an insufficient number of participants with the event.
NA Months
Interval 0.0 to 30.0
This value could not be determined due to an insufficient number of participants with the event.
NA Months
Interval 3.0 to 30.0
This value could not be determined due to an insufficient number of participants with the event.
—
—

SECONDARY outcome

Timeframe: 1 year

Population: Efficacy analyses for Arms A1, A2, and B were exploratory.

PFS at 1 year is defined as the proportion of participants with disease progression or relapse as determined by the investigator, or death from any cause within 1 year of randomization.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
PFS at 1 Year as Determined by the Investigator (Phase II)
77.47 Percentage of participants
Interval 63.65 to 91.29
70.83 Percentage of participants
Interval 55.59 to 86.07
81.82 Percentage of participants
Interval 65.7 to 97.94
—
—

SECONDARY outcome

Timeframe: Up to 50 months

Population: Efficacy analyses for Arms A1, A2, and B were exploratory. The number of participants analyzed reflects the number of participants with the event. The range (min-max) values are based on censored observations (participants without a baseline-evaluable tumor assessment or documentation of NALT were censored at the date of randomization or first study treatment, plus 1 day).

EFS is defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, initiation of new anti-lymphoma therapy (NALT), or death from any cause, whichever occurs first. The range values (min-max) are based on censored observations (if a participant did not experience disease progression or death prior to the end of the trial DOR was censored on the date of the last tumor assessment).

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=12 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=11 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=5 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Event-free Survival (EFS) as Determined by the Investigator (Phase II)
NA Months
Interval 2.0 to 31.0
This value could not be determined due to an insufficient number of participants with the event.
NA Months
Interval 0.0 to 30.0
This value could not be determined due to an insufficient number of participants with the event.
NA Months
Interval 3.0 to 30.0
This value could not be determined due to an insufficient number of participants with the event.
—
—

SECONDARY outcome

Timeframe: C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation)

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Time to Deterioration in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale
NA Months
Interval 2.3 to
Value was not estimable due to an insufficient number of participants with the event.
6.5 Months
Interval 2.1 to
Value was not estimable due to an insufficient number of participants with the event.
—
—
—

SECONDARY outcome

Timeframe: C1D1 through follow-up period (to begin 2 years after PRA or at the time of study drug discontinuation)

Population: The intent-to-treat (ITT) population consisted of all participants. Efficacy analyses for Arms A1, A2, and B were exploratory. Patient-reported outcomes (PROs) were evaluated only for Arm 1 and Arm 2 per protocol.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Time to Deterioration in Physical Functioning and Fatigue as Measured by the European Organization for Research and Treatment of Cancer Quality of Life - Core 30 Questionnaire (EORTC QLQ-C30)
2.3 Months
Interval 1.2 to 5.4
2.3 Months
Interval 0.8 to
Value was not estimable due to an insufficient number of participants with the event.
—
—
—

SECONDARY outcome

Timeframe: C2D1, C6D1

Population: Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=8 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Polatuzumab Vedotin Serum Concentrations
C2D1 pre-dose
0.993 ug/mL
Geometric Coefficient of Variation 779.4
1.99 ug/mL
Geometric Coefficient of Variation 80.7
1.73 ug/mL
Geometric Coefficient of Variation 107.9
—
—
Polatuzumab Vedotin Serum Concentrations
C6D1 pre-dose
2.76 ug/mL
Geometric Coefficient of Variation 820.1
8.13 ug/mL
Geometric Coefficient of Variation 34.5
5.8 ug/mL
Geometric Coefficient of Variation 42
—
—

SECONDARY outcome

Timeframe: C1D1-C6D1

Population: Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=8 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C1D2 24hrs post-dose
115 ng/mL
Geometric Coefficient of Variation 658.3
275 ng/mL
Geometric Coefficient of Variation 28.2
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C1D8 pre-dose
23 ng/mL
Geometric Coefficient of Variation 1040.4
42 ng/mL
Geometric Coefficient of Variation 82
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C1D15 pre-dose
8.22 ng/mL
Geometric Coefficient of Variation 550.4
13.2 ng/mL
Geometric Coefficient of Variation 87.4
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C2D1 pre-dose
4.87 ng/mL
Geometric Coefficient of Variation 626
6.81 ng/mL
Geometric Coefficient of Variation 80.1
7.09 ng/mL
Geometric Coefficient of Variation 95.5
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C2D1 post-dose
656 ng/mL
Geometric Coefficient of Variation 21.1
653 ng/mL
Geometric Coefficient of Variation 18
654 ng/mL
Geometric Coefficient of Variation 21
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C4D1 post-dose
783 ng/mL
Geometric Coefficient of Variation 26.5
614 ng/mL
Geometric Coefficient of Variation 15.4
696 ng/mL
Geometric Coefficient of Variation 24.1
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C5D1 pre-dose
7.14 ng/mL
Geometric Coefficient of Variation 343.5
19 ng/mL
Geometric Coefficient of Variation 39.7
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C5D1 post-dose
544 ng/mL
Geometric Coefficient of Variation 37.6
605 ng/mL
Geometric Coefficient of Variation 21.6
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C6D1 pre-dose
11.8 ng/mL
Geometric Coefficient of Variation 476.6
21.2 ng/mL
Geometric Coefficient of Variation 34.7
17.3 ng/mL
Geometric Coefficient of Variation 40.8
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C1D1 post-dose
620 ng/mL
Geometric Coefficient of Variation 54.5
668 ng/mL
Geometric Coefficient of Variation 21.2
584 ng/mL
Geometric Coefficient of Variation 23.1
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C1D2 pre-dose
219 ng/mL
Geometric Coefficient of Variation 412.2
—
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C3D1 pre-dose
19.2 ng/mL
Geometric Coefficient of Variation 58.7
15.8 ng/mL
Geometric Coefficient of Variation 39.5
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C3D1 post-dose
144 ng/mL
Geometric Coefficient of Variation 112947.3
544 ng/mL
Geometric Coefficient of Variation 90.7
—
—
—
Polatuzumab Vedotin Antibody-conjugated Monomethyl Auristatin E (acMMAE) Serum Concentrations
C4D1 pre-dose
16.8 ng/mL
Geometric Coefficient of Variation 79.6
16.8 ng/mL
Geometric Coefficient of Variation 50.3
15.6 ng/mL
Geometric Coefficient of Variation 41.4
—
—

SECONDARY outcome

Timeframe: C1D1-C6D1

Population: Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive polatuzumab vedotin were not included in this endpoint.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=8 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=40 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C1D1 post-dose
0.535 ng/mL
Geometric Coefficient of Variation 464.6
0.55 ng/mL
Geometric Coefficient of Variation 71.1
0.432 ng/mL
Geometric Coefficient of Variation 78.8
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C1D2 pre-dose
1.94 ng/mL
Geometric Coefficient of Variation 114.2
—
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C1D2 24hrs post-dose
3.3 ng/mL
Geometric Coefficient of Variation 97.8
2.82 ng/mL
Geometric Coefficient of Variation 51.9
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C1D8 pre-dose
2.95 ng/mL
Geometric Coefficient of Variation 80.9
1.27 ng/mL
Geometric Coefficient of Variation 93.6
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C1D15 pre-dose
0.604 ng/mL
Geometric Coefficient of Variation 113.3
0.301 ng/mL
Geometric Coefficient of Variation 104.1
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C2D1 pre-dose
0.187 ng/mL
Geometric Coefficient of Variation 47.3
0.0773 ng/mL
Geometric Coefficient of Variation 110.2
0.0697 ng/mL
Geometric Coefficient of Variation 87
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C2D1 post-dose
0.238 ng/mL
Geometric Coefficient of Variation 64
0.137 ng/mL
Geometric Coefficient of Variation 84
0.116 ng/mL
Geometric Coefficient of Variation 56.3
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C3D1 pre-dose
0.168 ng/mL
Geometric Coefficient of Variation 92
0.146 ng/mL
Geometric Coefficient of Variation 96.9
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C3D1 post-dose
0.111 ng/mL
Geometric Coefficient of Variation 173.9
0.203 ng/mL
Geometric Coefficient of Variation 92.7
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C4D1 pre-dose
0.0491 ng/mL
Geometric Coefficient of Variation NA
If more than one-third of values were lower than reportable, only the median, maximum, and geometric mean are reported.
0.14 ng/mL
Geometric Coefficient of Variation 93.8
0.106 ng/mL
Geometric Coefficient of Variation 88.9
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C4D1 post-dose
0.0825 ng/mL
Geometric Coefficient of Variation 188.3
0.186 ng/mL
Geometric Coefficient of Variation 66.1
0.164 ng/mL
Geometric Coefficient of Variation 43.6
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C5D1 pre-dose
0.0741 ng/mL
Geometric Coefficient of Variation 247
0.137 ng/mL
Geometric Coefficient of Variation 74.4
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C5D1 post-dose
0.212 ng/mL
Geometric Coefficient of Variation 54.2
0.17 ng/mL
Geometric Coefficient of Variation 38.1
—
—
—
Polatuzumab Vedotin Unconjugated Mono-methyl Auristatin E (MMAE) Serum Concentrations
C6D1 pre-dose
0.0967 ng/mL
Geometric Coefficient of Variation 194.2
0.142 ng/mL
Geometric Coefficient of Variation 63.8
0.0974 ng/mL
Geometric Coefficient of Variation 82.4
—
—

SECONDARY outcome

Timeframe: C1D1-C5D1

Population: Participants with at least one pharmacokinetic (PK) sample were included in analysis. Arms in which participants did not receive mosunetuzumab were not included in this endpoint.

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=3 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=4 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=8 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
n=40 Participants
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=40 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Mosunetuzumab Serum Concentrations
C4D1 pre-dose
0.502 ug/mL
Geometric Coefficient of Variation 36.9
1.09 ug/mL
Geometric Coefficient of Variation 44.4
0.782 ug/mL
Geometric Coefficient of Variation 90
1.03 ug/mL
Geometric Coefficient of Variation 33.9
0.932 ug/mL
Geometric Coefficient of Variation 52
Mosunetuzumab Serum Concentrations
C1D1 post-dose
0.157 ug/mL
Geometric Coefficient of Variation 22.1
0.181 ug/mL
Geometric Coefficient of Variation 26.7
—
0.155 ug/mL
Geometric Coefficient of Variation 34.1
0.132 ug/mL
Geometric Coefficient of Variation 73.2
Mosunetuzumab Serum Concentrations
C1D1 2 hrs post-dose
0.152 ug/mL
Geometric Coefficient of Variation 27.8
0.163 ug/mL
Geometric Coefficient of Variation 25.8
—
0.151 ug/mL
Geometric Coefficient of Variation 28.1
—
Mosunetuzumab Serum Concentrations
C1D2 2 hrs post-dose
—
—
0.145 ug/mL
Geometric Coefficient of Variation 80
—
—
Mosunetuzumab Serum Concentrations
C1D2 24 hrs post-dose
0.103 ug/mL
Geometric Coefficient of Variation 23.3
0.112 ug/mL
Geometric Coefficient of Variation 8.1
0.0947 ug/mL
Geometric Coefficient of Variation 60.2
0.096 ug/mL
Geometric Coefficient of Variation 35.7
0.0825 ug/mL
Geometric Coefficient of Variation 46.1
Mosunetuzumab Serum Concentrations
C1D8 pre-dose
0.0331 ug/mL
Geometric Coefficient of Variation 49
0.0218 ug/mL
Geometric Coefficient of Variation 153.2
0.0334 ug/mL
Geometric Coefficient of Variation 113.6
0.0253 ug/mL
Geometric Coefficient of Variation 62.2
0.0263 ug/mL
Geometric Coefficient of Variation 77
Mosunetuzumab Serum Concentrations
C1D8 post-dose
0.342 ug/mL
Geometric Coefficient of Variation 18.8
0.427 ug/mL
Geometric Coefficient of Variation 36.2
0.354 ug/mL
Geometric Coefficient of Variation 36.9
0.426 ug/mL
Geometric Coefficient of Variation 30.3
0.376 ug/mL
Geometric Coefficient of Variation 38.8
Mosunetuzumab Serum Concentrations
C1D8 2hrs post-dose
0.32 ug/mL
Geometric Coefficient of Variation 28.5
0.409 ug/mL
Geometric Coefficient of Variation 50.1
0.349 ug/mL
Geometric Coefficient of Variation 43.1
0.388 ug/mL
Geometric Coefficient of Variation 27.6
—
Mosunetuzumab Serum Concentrations
C1D15 pre-dose
0.0866 ug/mL
Geometric Coefficient of Variation 47.9
0.0884 ug/mL
Geometric Coefficient of Variation 52.8
0.0911 ug/mL
Geometric Coefficient of Variation 57.7
0.0953 ug/mL
Geometric Coefficient of Variation 41.8
0.102 ug/mL
Geometric Coefficient of Variation 47.7
Mosunetuzumab Serum Concentrations
C1D15 post-dose
2.83 ug/mL
Geometric Coefficient of Variation 22.6
5.71 ug/mL
Geometric Coefficient of Variation 38.6
5.72 ug/mL
Geometric Coefficient of Variation 44
7.13 ug/mL
Geometric Coefficient of Variation 27.7
6.31 ug/mL
Geometric Coefficient of Variation 34.8
Mosunetuzumab Serum Concentrations
C1D15 2 hrs post-dose
2.28 ug/mL
Geometric Coefficient of Variation 7.5
5.66 ug/mL
Geometric Coefficient of Variation 38.7
5.92 ug/mL
Geometric Coefficient of Variation 18.5
6.56 ug/mL
Geometric Coefficient of Variation 28.4
—
Mosunetuzumab Serum Concentrations
C2D1 pre-dose
0.549 ug/mL
Geometric Coefficient of Variation 24.3
1.52 ug/mL
Geometric Coefficient of Variation 49.4
—
1.67 ug/mL
Geometric Coefficient of Variation 32.1
1.46 ug/mL
Geometric Coefficient of Variation 62.8
Mosunetuzumab Serum Concentrations
C2D1 post-dose
2.86 ug/mL
Geometric Coefficient of Variation 7.2
6.75 ug/mL
Geometric Coefficient of Variation 42.2
—
8.31 ug/mL
Geometric Coefficient of Variation 27.4
7.69 ug/mL
Geometric Coefficient of Variation 38.3
Mosunetuzumab Serum Concentrations
C2D1 2 hrs post-dose
2.38 ug/mL
Geometric Coefficient of Variation 1.2
7.33 ug/mL
Geometric Coefficient of Variation 44.7
7.65 ug/mL
Geometric Coefficient of Variation 35.1
8.28 ug/mL
Geometric Coefficient of Variation 26.7
—
Mosunetuzumab Serum Concentrations
C2D2 pre-dose
—
—
1.37 ug/mL
Geometric Coefficient of Variation 38.6
—
—
Mosunetuzumab Serum Concentrations
C2D2 post-dose
—
—
8.9 ug/mL
Geometric Coefficient of Variation 34.1
—
—
Mosunetuzumab Serum Concentrations
C3D1 pre-dose
0.458 ug/mL
Geometric Coefficient of Variation 36.3
1.08 ug/mL
Geometric Coefficient of Variation 53.3
1.21 ug/mL
Geometric Coefficient of Variation 45.1
1.11 ug/mL
Geometric Coefficient of Variation 30.2
0.885 ug/mL
Geometric Coefficient of Variation 43
Mosunetuzumab Serum Concentrations
C3D1 post-dose
3.37 ug/mL
Geometric Coefficient of Variation 23.4
7.19 ug/mL
Geometric Coefficient of Variation 30.8
6.66 ug/mL
Geometric Coefficient of Variation 41.3
7.3 ug/mL
Geometric Coefficient of Variation 39.2
6.76 ug/mL
Geometric Coefficient of Variation 28.9
Mosunetuzumab Serum Concentrations
C4D1 post-dose
3.24 ug/mL
Geometric Coefficient of Variation 31.3
7.38 ug/mL
Geometric Coefficient of Variation 26.3
4.09 ug/mL
Geometric Coefficient of Variation 83
7.41 ug/mL
Geometric Coefficient of Variation 44
5.55 ug/mL
Geometric Coefficient of Variation 80.3
Mosunetuzumab Serum Concentrations
C5D1 pre-dose
0.426 ug/mL
Geometric Coefficient of Variation 51.7
1.02 ug/mL
Geometric Coefficient of Variation 62
0.33 ug/mL
Geometric Coefficient of Variation 176.6
1.12 ug/mL
Geometric Coefficient of Variation 31.6
0.935 ug/mL
Geometric Coefficient of Variation 106.1

SECONDARY outcome

Timeframe: Cycles 1, 2, 6, 16, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment)

Population: The immunogenicity analysis population included all participants with at least one ADA assessment. The number of participants analyzed are the values for baseline-evaluable participants and post-baseline evaluable participants.

Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected).

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=3 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=4 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=8 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
n=40 Participants
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=38 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Positive sample at baseline
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Not positive at baseline
3 Number of participants
4 Number of participants
8 Number of participants
38 Number of participants
33 Number of participants
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Positive for treatment-emergent ADA
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Positive for treatment-induced ADA
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Positive for treatment-enhanced ADA
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
0 Number of participants
Baseline Prevalence and Incidence of Treatment Emergent Anti-drug Antibodies (ADA) to Mosunetuzumab
Negative for treatment-emergent ADA
3 Number of participants
4 Number of participants
6 Number of participants
39 Number of participants
37 Number of participants

SECONDARY outcome

Timeframe: Cycles 1, 2, 6, and at early discontinuation visit or at PRA (6-8 weeks after either C6D1 or last dose of study treatment)

Population: The immunogenicity analysis population included all participants with at least one ADA assessment. The number of participants analyzed are the values for baseline-evaluable participants and post-baseline evaluable participants.

Participants are considered to have treatment-induced ADA responses if they are ADA negative or missing data at baseline and then develop an ADA response following study drug administration. Participants are considered to have treatment-enhanced ADA responses if they are ADA positive at baseline and the titer of one or more post baseline samples is at least 4-fold greater than the titer of the baseline sample. Patients are considered to be negative for ADAs if they are ADA negative at all timepoints or if they are ADA positive at baseline but do not have any post-baseline samples with a titer that is at least 4-fold greater than the titer of the baseline sample (treatment unaffected).

Outcome measures

Outcome measures
Measure
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=8 Participants
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=38 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 Participants
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Positive sample at baseline
0 Number of participants
1 Number of participants
2 Number of participants
—
—
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Not positive at baseline
8 Number of participants
32 Number of participants
19 Number of participants
—
—
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Positive for treatment-emergent ADA
0 Number of participants
0 Number of participants
1 Number of participants
—
—
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Positive for treatment-induced ADA
0 Number of participants
0 Number of participants
1 Number of participants
—
—
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Positive for treatment-enhanced ADA
0 Number of participants
0 Number of participants
0 Number of participants
—
—
Baseline Prevalence and Incidence of Treatment Emergent ADA to Polatuzumab Vedotin
Negative for treatment-emergent ADA
6 Number of participants
37 Number of participants
20 Number of participants
—
—

Adverse Events

Group A1: Phase Ib Mosunetuzumab + CHOP

Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths

Group A2: Phase Ib Mosunetuzumab + CHOP

Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths

Group B: Phase Ib Mosunetuzumab + CHP-Pola

Serious events: 6 serious events
Other events: 8 other events
Deaths: 6 deaths

Group C: Phase II Mosunetuzumab + CHOP

Serious events: 20 serious events
Other events: 40 other events
Deaths: 9 deaths

Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)

Serious events: 24 serious events
Other events: 38 other events
Deaths: 5 deaths

Arm 2: Phase II Rituximab + CHP-Pola (Randomized)

Serious events: 3 serious events
Other events: 22 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
Group A1: Phase Ib Mosunetuzumab + CHOP
n=3 participants at risk
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Group A2: Phase Ib Mosunetuzumab + CHOP
n=4 participants at risk
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
Group B: Phase Ib Mosunetuzumab + CHP-Pola
n=8 participants at risk
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
n=40 participants at risk
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=38 participants at risk
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 participants at risk
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Blood and lymphatic system disorders
Anaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.2%
5/38 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Acute myocardial infarction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Angina unstable
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Cardiac failure
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Cardiac tamponade
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Supraventricular tachycardia
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Colitis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Constipation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Diarrhoea
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Large intestinal haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Nausea
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Neutropenic colitis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Oesophageal fistula
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Vomiting
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Chest pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Death
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Fatigue
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Mucosal inflammation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Peripheral swelling
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Pyrexia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Ulcer
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Hepatobiliary disorders
Congestive hepatopathy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Immune system disorders
Cytokine release syndrome
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.2%
5/38 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
COVID-19
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Cellulitis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Cytomegalovirus infection reactivation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Enterocolitis infectious
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Fungal oesophagitis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Gastroenteritis norovirus
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Herpes zoster
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Influenza
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Klebsiella infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Pneumocystis jirovecii pneumonia
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Pneumonia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Pneumonia aspiration
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Sepsis
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Septic shock
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Soft tissue infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Urinary tract infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Vascular device infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Anastomotic leak
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Anastomotic ulcer
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Concussion
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Fall
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Neutrophil count decreased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
SARS-CoV-2 test positive
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Troponin I increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Fistula
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Cerebrovascular accident
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Coma
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Dizziness
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Encephalopathy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Headache
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Hepatic encephalopathy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Lethargy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Syncope
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Mental status changes
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Aortic rupture
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Hypotension
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.

Other adverse events

Other adverse events
Measure
Group A1: Phase Ib Mosunetuzumab + CHOP
n=3 participants at risk
Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Group A2: Phase Ib Mosunetuzumab + CHOP
n=4 participants at risk
Participants with relapsed/refractory (R/R) B-cell NHL received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5. Treatment was given for 6 cycles (cycle length = 21 days).
Group B: Phase Ib Mosunetuzumab + CHP-Pola
n=8 participants at risk
Participants with R/R NHL received 6 cycles of mosunetuzumab (M) + cyclophosphamide, doxorubicin, prednisone (CHP), and polatuzumab vedotin (Pola) (cycle length = 21 days). Participants received M on C1D2, C1D8, C1D15, C2D2, and on D1 of subsequent cycles if well tolerated. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Group C: Phase II Mosunetuzumab + CHOP
n=40 participants at risk
Participants with previously untreated diffuse large B-cell lymphoma (DLBCL) received mosunetuzumab on Cycle 1 Day 1 (C1D1), C1D8, and C1D15, then on Day 1 of subsequent cycles. In addition, participants received cyclophosphamide, doxorubicin, and vincristine on D1, and prednisone on D1-D5 (CHOP). Treatment was given for 6 cycles (cycle length = 21 days).
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
n=38 participants at risk
Participants received M-CHP-Pola for 6 cycles (cycle length = 21 days). Participants received M on C1D1, C1D8, and C1D15, then on D1 of subsequent cycles. CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
n=22 participants at risk
Participants received R-CHP-Pola for 6 cycles (cycle length = 21 days). R-CHP-pola was given on D1 of each cycle (D1-D5 for prednisone).
Injury, poisoning and procedural complications
Contusion
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Fall
66.7%
2/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Sepsis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Skin candida
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Upper respiratory tract infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Urinary tract infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Anaemia
66.7%
2/3 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
42.5%
17/40 • Number of events 35 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
23.7%
9/38 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
22.7%
5/22 • Number of events 11 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Neutropenia
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
4/8 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
47.5%
19/40 • Number of events 30 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
36.8%
14/38 • Number of events 24 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
31.8%
7/22 • Number of events 11 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Splenomegaly
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Blood and lymphatic system disorders
Thrombocytopenia
66.7%
2/3 • Number of events 20 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 11 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
5/40 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 10 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Atrial flutter
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Left ventricular dysfunction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Palpitations
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Supraventricular tachycardia
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Cardiac disorders
Tachycardia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
5/40 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Ear and labyrinth disorders
Vertigo
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Eye disorders
Dry eye
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Eye disorders
Halo vision
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Eye disorders
Lacrimation increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Eye disorders
Retinopathy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Eye disorders
Vision blurred
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Eye disorders
Vitreous floaters
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Abdominal pain
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
20.0%
8/40 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Anal incontinence
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Colonic haematoma
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Constipation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
35.0%
14/40 • Number of events 17 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.2%
4/22 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Diarrhoea
66.7%
2/3 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
30.0%
12/40 • Number of events 14 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
31.6%
12/38 • Number of events 17 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.2%
4/22 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Dry mouth
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Dyspepsia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Gastritis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Lip dry
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Nausea
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
75.0%
6/8 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
55.0%
22/40 • Number of events 33 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
44.7%
17/38 • Number of events 24 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
40.9%
9/22 • Number of events 10 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Oral pain
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Stomatitis
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Gastrointestinal disorders
Vomiting
33.3%
1/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
27.5%
11/40 • Number of events 18 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
23.7%
9/38 • Number of events 11 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
22.7%
5/22 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Asthenia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Chest discomfort
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Chest pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Chills
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
5/40 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Fatigue
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
62.5%
5/8 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
47.5%
19/40 • Number of events 23 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
31.6%
12/38 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
45.5%
10/22 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Generalised oedema
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Injection site pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Non-cardiac chest pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Oedema peripheral
66.7%
2/3 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
20.0%
8/40 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.2%
5/38 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
General disorders
Pyrexia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
20.0%
8/40 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Immune system disorders
Cytokine release syndrome
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
60.0%
24/40 • Number of events 30 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
57.9%
22/38 • Number of events 27 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Bacteraemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Candida infection
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Clostridium difficile colitis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Cytomegalovirus viraemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Herpes zoster
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Influenza
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Oral candidiasis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Pneumonia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Infections and infestations
Pseudomonal bacteraemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Febrile nonhaemolytic transfusion reaction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
23.7%
9/38 • Number of events 10 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Vascular access complication
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Vascular access site haemorrhage
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Injury, poisoning and procedural complications
Vascular access site pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Alanine aminotransferase increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
26.3%
10/38 • Number of events 10 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.2%
4/22 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
5/40 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Blood alkaline phosphatase increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Blood bilirubin increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Blood creatinine increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
International normalised ratio increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Liver function test increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Lymphocyte count decreased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 19 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Neutrophil count decreased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
20.0%
8/40 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
28.9%
11/38 • Number of events 18 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
22.7%
5/22 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Platelet count decreased
66.7%
2/3 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 11 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
5/40 • Number of events 12 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Serum ferritin increased
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
Weight decreased
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Investigations
White blood cell count decreased
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 10 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 12 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Decreased appetite
66.7%
2/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
4/8 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
15/40 • Number of events 17 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
28.9%
11/38 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypervolaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 14 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypokalaemia
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
62.5%
5/8 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
32.5%
13/40 • Number of events 25 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypomagnesaemia
66.7%
2/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
62.5%
5/8 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hyponatraemia
33.3%
1/3 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
17.5%
7/40 • Number of events 12 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Metabolic acidosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.2%
5/38 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Ageusia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Dizziness
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
22.5%
9/40 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Dysgeusia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
17.5%
7/40 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Encephalopathy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Facial paralysis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Headache
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
22.5%
9/40 • Number of events 14 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
31.8%
7/22 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Horner's syndrome
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Hypoaesthesia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Lacunar infarction
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Memory impairment
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Neuropathy peripheral
66.7%
2/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
32.5%
13/40 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.9%
3/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.2%
4/22 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Paraesthesia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.2%
5/38 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.2%
4/22 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Taste disorder
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Nervous system disorders
Tremor
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Agitation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Anxiety
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Confusional state
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Depression
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Hallucination
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Insomnia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
37.5%
3/8 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.0%
6/40 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
27.3%
6/22 • Number of events 6 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Psychiatric disorders
Restlessness
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Acute kidney injury
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Chromaturia
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Dysuria
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Haematuria
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Micturition urgency
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Pollakiuria
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Proteinuria
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Urinary incontinence
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Renal and urinary disorders
Urinary retention
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
17.5%
7/40 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
17.5%
7/40 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
13.6%
3/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Hiccups
33.3%
1/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
7.5%
3/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
2/8 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
9.1%
2/22 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Alopecia
33.3%
1/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
30.0%
12/40 • Number of events 12 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.4%
7/38 • Number of events 7 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
40.9%
9/22 • Number of events 9 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Dry skin
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Nail disorder
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.5%
4/38 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Rash
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
10.0%
4/40 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
15.8%
6/38 • Number of events 8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
18.2%
4/22 • Number of events 4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
50.0%
2/4 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.0%
2/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Skin and subcutaneous tissue disorders
Urticaria
33.3%
1/3 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.6%
1/38 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Deep vein thrombosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
2.5%
1/40 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Hypertension
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 5 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Hypotension
33.3%
1/3 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
22.5%
9/40 • Number of events 13 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
5.3%
2/38 • Number of events 2 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Jugular vein thrombosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Orthostatic hypotension
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Pallor
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
25.0%
1/4 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/8 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/22 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
Vascular disorders
Superficial vein thrombosis
0.00%
0/3 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/4 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
12.5%
1/8 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/40 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
0.00%
0/38 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.
4.5%
1/22 • Number of events 1 • Up to approximately 30 months.
All-cause mortality includes the entire population. Serious and non-serious adverse events are reported for the safety population, which consisted of all participants who received at least one dose of study drug, with participants grouped according to treatment received.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER