Trial Outcomes & Findings for A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (NCT NCT03602859)

NCT ID: NCT03602859

Last Updated: 2025-12-31

Results Overview

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

1400 participants

Primary outcome timeframe

Up to approximately 316 weeks

Results posted on

2025-12-31

Participant Flow

The results presented are based on primary completion date. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.

Participant milestones

Participant milestones
Measure
All Enrolled Participants
Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter\^2(m\^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period.
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1)
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo (Pbo) on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles starting with Cycle 2, with optional Bevacizumab (Bev) as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib placebo Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Chemotherapy Run-In Period (Cycle 1)
STARTED
1400
0
0
0
Chemotherapy Run-In Period (Cycle 1)
COMPLETED
1321
0
0
0
Chemotherapy Run-In Period (Cycle 1)
NOT COMPLETED
79
0
0
0
Chemo Treatment Period (Cycle 2 to 6)
STARTED
0
159
417
745
Chemo Treatment Period (Cycle 2 to 6)
ITT Population
0
193
385
753
Chemo Treatment Period (Cycle 2 to 6)
COMPLETED
0
129
371
645
Chemo Treatment Period (Cycle 2 to 6)
NOT COMPLETED
0
30
46
100
Maintenance Period (Cycle 7 to 89)
STARTED
0
129
371
645
Maintenance Period (Cycle 7 to 89)
COMPLETED
0
5
41
77
Maintenance Period (Cycle 7 to 89)
NOT COMPLETED
0
124
330
568

Reasons for withdrawal

Reasons for withdrawal
Measure
All Enrolled Participants
Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter\^2(m\^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period.
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1)
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo (Pbo) on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles starting with Cycle 2, with optional Bevacizumab (Bev) as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib placebo Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Chemotherapy Run-In Period (Cycle 1)
Adverse Event
10
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Disease Progression per Clinical Criteria by Investigator
2
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Risk to Patient
3
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Severe Noncompliance to Protocol
6
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Withdrawal by Subject
10
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Death
10
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Other
27
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Missing
1
0
0
0
Chemotherapy Run-In Period (Cycle 1)
Randomized but not treated
10
0
0
0
Chemo Treatment Period (Cycle 2 to 6)
Investigator decision
0
1
5
3
Chemo Treatment Period (Cycle 2 to 6)
Adverse Event
0
7
11
25
Chemo Treatment Period (Cycle 2 to 6)
Progression/clinical progression
0
7
14
15
Chemo Treatment Period (Cycle 2 to 6)
Risk to Patient
0
2
1
5
Chemo Treatment Period (Cycle 2 to 6)
Severe Noncompliance to Protocol
0
2
2
8
Chemo Treatment Period (Cycle 2 to 6)
Withdrawal by Subject
0
9
11
29
Chemo Treatment Period (Cycle 2 to 6)
Lost to Follow-up
0
0
0
1
Chemo Treatment Period (Cycle 2 to 6)
Death
0
1
1
5
Chemo Treatment Period (Cycle 2 to 6)
Other
0
1
1
9
Maintenance Period (Cycle 7 to 89)
Ongoing
0
3
23
42
Maintenance Period (Cycle 7 to 89)
Adverse Event
0
6
24
91
Maintenance Period (Cycle 7 to 89)
Thrombocytopenia Platelet Count not Returned to >=100000 cells/uL w/in
0
0
1
2
Maintenance Period (Cycle 7 to 89)
Progression/clinical progression
0
83
251
356
Maintenance Period (Cycle 7 to 89)
Risk to Patient
0
2
1
2
Maintenance Period (Cycle 7 to 89)
Severe Noncompliance to Protocol
0
3
3
5
Maintenance Period (Cycle 7 to 89)
Withdrawal by Subject
0
7
22
48
Maintenance Period (Cycle 7 to 89)
Lost to Follow-up
0
0
2
2
Maintenance Period (Cycle 7 to 89)
Death
0
0
1
7
Maintenance Period (Cycle 7 to 89)
Unblinded due to being randomized to Arm 1
0
18
0
0
Maintenance Period (Cycle 7 to 89)
Investigator decision
0
0
0
1
Maintenance Period (Cycle 7 to 89)
Other
0
2
2
12

Baseline Characteristics

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Enrolled Participants
n=1400 Participants
Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter\^2(m\^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period.
Age, Continuous
62.0 YEARS
STANDARD_DEVIATION 10.81 • n=1000 Participants
Sex: Female, Male
Female
1400 Participants
n=1000 Participants
Sex: Female, Male
Male
0 Participants
n=1000 Participants
Race/Ethnicity, Customized
White
1245 Participants
n=1000 Participants
Race/Ethnicity, Customized
Black or African American
30 Participants
n=1000 Participants
Race/Ethnicity, Customized
Asian
29 Participants
n=1000 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
8 Participants
n=1000 Participants
Race/Ethnicity, Customized
Unknown
80 Participants
n=1000 Participants
Race/Ethnicity, Customized
Not Reported
8 Participants
n=1000 Participants

PRIMARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Progression Free Survival (PFS)
19.19 Months
Interval 16.59 to 20.99
20.63 Months
Interval 19.22 to 22.77

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Overall Survival (OS) is defined as the time from the date of randomization to the date of death by any cause.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Overall Survival (OS)
45.37 Months
Interval 40.28 to 52.21
44.39 Months
Interval 41.17 to 47.54

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first determined by the BICR according to RECIST version 1.1. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
PFS Determined by Blinded Independent Central Review (BICR) Per RECIST v1.1 Criteria
23.56 Months
Interval 20.14 to 27.4
25.89 Months
Interval 23.36 to 32.49

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Time to First Subsequent Therapy (TFST) is defined as the time from randomization until the start date of the first subsequent anticancer therapy or death by any cause, whichever occurs first. First subsequent anticancer therapy is defined as the earliest anticancer therapy on the follow-up anticancer therapy form.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Time to First Subsequent Therapy (TFST)
20.93 Months
Interval 17.58 to 22.67
20.86 Months
Interval 19.15 to 23.92

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Time to Second Subsequent Therapy (TSST) is defined as the time from the date of randomization to the start date of the second subsequent anticancer therapy or death of any cause, whichever occurs first. Second subsequent anticancer therapy is defined as an anticancer therapy with a start date after the first subsequent anticancer therapy and a recorded PD on first subsequent anticancer therapy, as captured on the follow-up anticancer therapy eCRF form.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Time to Second Subsequent Therapy (TSST)
33.97 Months
Interval 30.06 to 37.49
35.32 Months
Interval 32.46 to 38.31

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

PFS2 is defined as the time from the date of randomization to the date of first Progressive Disease per Investigator's assessment after initiation of subsequent anticancer therapy or death due to any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Time to Second Progression (PFS2)
31.84 Months
Interval 28.65 to 35.09
32.69 Months
Interval 30.42 to 35.38

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Objective Response Rate (ORR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR) or partial response (PR) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Objective Response Rate (ORR)
88 Percentage of participants
Interval 83.7 to 91.6
88.4 Percentage of participants
Interval 85.5 to 90.9

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

DOR is defined as the time from the first documented response (complete response (CR) OR partial response (PR) ) to the first documented disease progression per Investigator assessed RECIST v1.1 or death by any cause in participants with measurable disease at baseline who responded to treatment. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=250 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=496 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Duration of Response (DOR)
16.07 Months
Interval 13.86 to 18.4
18.27 Months
Interval 16.36 to 20.53

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: The Intent-to-Treat (ITT) population included all randomized participants. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

Disease Control Rate (DCR) is defined as the percentage of participants with measurable disease at baseline achieving a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) by Investigator assessment per RECIST v1.1 criteria for participants with measurable disease at baseline. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions. SD defined as any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=385 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=753 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Disease Control Rate (DCR)
93.7 Percentage of participants
Interval 90.2 to 96.2
93.6 Percentage of participants
Interval 91.2 to 95.5

SECONDARY outcome

Timeframe: Up to approximately 316 weeks

Population: Anti-drug antibody (ADA) population included all participants from Arm 3 only who received at least one dose of dostarlimab and who had at least 1 ADA sample with an assay result.

Serum samples were collected for the analysis of Anti-drug antibody (ADAs) of dostarlimab.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=745 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Number of Participants With Treatment Emergent Positive Antidrug Antibodies (ADAs) of Dostarlimab
17 Participants

SECONDARY outcome

Timeframe: Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)

Population: ITT Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

EQ-5D-5L is a standardized, participant-rated health outcomes questionnaire covering five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of dimensions, participant self-assigned score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems). VAS is collected separately and recorded from 0 (Worst imaginable health state) to 100 (Best imaginable health state). HUI values summarize how good or bad each health state is on a scale of 1 (full health) to 0 (worse health/dead). High HUI value indicates a good HRQoL. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment (EOT).

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=330 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=655 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 17 Maintenance
14.8 Scores on a scale
Standard Deviation 26.29
11.5 Scores on a scale
Standard Deviation 19.81
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 41 Maintenance
9.8 Scores on a scale
Standard Deviation 22.91
10.1 Scores on a scale
Standard Deviation 18.96
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 89 Maintenance
-5.0 Scores on a scale
Standard Deviation NA
Standard deviation is not applicable as only a single participant was analyzed.
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 33 months
4.6 Scores on a scale
Standard Deviation 21.75
9.2 Scores on a scale
Standard Deviation 17.02
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 45 months
5.5 Scores on a scale
Standard Deviation 19.23
-4.7 Scores on a scale
Standard Deviation 16.00
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 21 months
-0.0370 Scores on a scale
Standard Deviation 0.16768
-0.0457 Scores on a scale
Standard Deviation 0.26270
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 4 Chemotherapy
1.2 Scores on a scale
Standard Deviation 18.33
0.1 Scores on a scale
Standard Deviation 18.00
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 6 Chemotherapy
4.6 Scores on a scale
Standard Deviation 18.84
2.0 Scores on a scale
Standard Deviation 18.69
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 1 Maintenance
5.9 Scores on a scale
Standard Deviation 19.99
3.2 Scores on a scale
Standard Deviation 18.25
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 2 Maintenance
6.9 Scores on a scale
Standard Deviation 19.03
2.9 Scores on a scale
Standard Deviation 19.52
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 3 Maintenance
4.9 Scores on a scale
Standard Deviation 20.42
4.9 Scores on a scale
Standard Deviation 19.32
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 6 Maintenance
5.1 Scores on a scale
Standard Deviation 17.81
5.3 Scores on a scale
Standard Deviation 18.80
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 9 Maintenance
7.6 Scores on a scale
Standard Deviation 19.74
6.6 Scores on a scale
Standard Deviation 18.09
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 12 Maintenance
9.6 Scores on a scale
Standard Deviation 20.58
6.6 Scores on a scale
Standard Deviation 17.59
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 15 Maintenance
8.1 Scores on a scale
Standard Deviation 23.56
6.6 Scores on a scale
Standard Deviation 17.72
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 23 Maintenance
13.3 Scores on a scale
Standard Deviation 22.95
10.4 Scores on a scale
Standard Deviation 20.89
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 29 Maintenance
12.5 Scores on a scale
Standard Deviation 22.27
10.3 Scores on a scale
Standard Deviation 19.06
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 35 Maintenance
9.9 Scores on a scale
Standard Deviation 19.00
10.4 Scores on a scale
Standard Deviation 16.55
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 47 Maintenance
8.8 Scores on a scale
Standard Deviation 21.16
10.9 Scores on a scale
Standard Deviation 18.39
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 53 Maintenance
8.5 Scores on a scale
Standard Deviation 25.94
11.4 Scores on a scale
Standard Deviation 18.65
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 59 Maintenance
7.3 Scores on a scale
Standard Deviation 25.15
10.7 Scores on a scale
Standard Deviation 18.14
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 65 Maintenance
2.5 Scores on a scale
Standard Deviation 11.10
14.9 Scores on a scale
Standard Deviation 19.55
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 71 Maintenance
5.9 Scores on a scale
Standard Deviation 10.78
13.0 Scores on a scale
Standard Deviation 17.09
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 77 Maintenance
9.3 Scores on a scale
Standard Deviation 9.84
15.9 Scores on a scale
Standard Deviation 18.65
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Cycle 83 Maintenance
9.7 Scores on a scale
Standard Deviation 6.35
19.3 Scores on a scale
Standard Deviation 21.45
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, End of Treatment
0.7 Scores on a scale
Standard Deviation 21.93
-0.1 Scores on a scale
Standard Deviation 22.51
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Safety Follow-up
3.5 Scores on a scale
Standard Deviation 21.89
-0.1 Scores on a scale
Standard Deviation 21.45
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, Long term Follow-up (LTFU) EOT + 3 months
3.0 Scores on a scale
Standard Deviation 21.47
2.7 Scores on a scale
Standard Deviation 20.06
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 9 months
1.1 Scores on a scale
Standard Deviation 18.14
2.4 Scores on a scale
Standard Deviation 21.53
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 15 months
2.3 Scores on a scale
Standard Deviation 21.57
4.3 Scores on a scale
Standard Deviation 19.29
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 21 months
1.8 Scores on a scale
Standard Deviation 19.39
1.8 Scores on a scale
Standard Deviation 24.79
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 27 months
5.5 Scores on a scale
Standard Deviation 15.87
5.0 Scores on a scale
Standard Deviation 21.42
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 39 months
5.9 Scores on a scale
Standard Deviation 22.38
-1.9 Scores on a scale
Standard Deviation 13.89
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 51 months
0.0 Scores on a scale
Standard Deviation 0.0
3.6 Scores on a scale
Standard Deviation 11.50
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 57 months
2.5 Scores on a scale
Standard Deviation 3.54
-12.0 Scores on a scale
Standard Deviation NA
Standard deviation is not applicable as only a single participant was analyzed.
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
EQ-VAS, LTFU-EOT + 63 months
0.0 Scores on a scale
Standard Deviation NA
Standard deviation is not applicable as only a single participant was analyzed.
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 4 Chemotherapy
-0.0033 Scores on a scale
Standard Deviation 0.16847
-0.0035 Scores on a scale
Standard Deviation 0.19281
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 6 Chemotherapy
-0.0049 Scores on a scale
Standard Deviation 0.18207
-0.0065 Scores on a scale
Standard Deviation 0.19647
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 1 Maintenance
0.0034 Scores on a scale
Standard Deviation 0.19324
-0.0043 Scores on a scale
Standard Deviation 0.20270
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 2 Maintenance
0.0118 Scores on a scale
Standard Deviation 0.18781
0.0036 Scores on a scale
Standard Deviation 0.20052
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 3 Maintenance
-0.0015 Scores on a scale
Standard Deviation 0.21441
-0.0073 Scores on a scale
Standard Deviation 0.21785
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 6 Maintenance
0.0184 Scores on a scale
Standard Deviation 0.21704
0.0029 Scores on a scale
Standard Deviation 0.19389
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 9 Maintenance
0.0281 Scores on a scale
Standard Deviation 0.19001
0.0181 Scores on a scale
Standard Deviation 0.20597
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 12 Maintenance
0.0326 Scores on a scale
Standard Deviation 0.21333
0.0177 Scores on a scale
Standard Deviation 0.19577
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 15 Maintenance
0.0379 Scores on a scale
Standard Deviation 0.21060
0.0136 Scores on a scale
Standard Deviation 0.18809
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 17 Maintenance
0.0777 Scores on a scale
Standard Deviation 0.23603
0.0545 Scores on a scale
Standard Deviation 0.19913
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 23 Maintenance
0.0353 Scores on a scale
Standard Deviation 0.16562
0.0012 Scores on a scale
Standard Deviation 0.22021
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 29 Maintenance
0.0610 Scores on a scale
Standard Deviation 0.23268
0.0058 Scores on a scale
Standard Deviation 0.18551
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 35 Maintenance
0.0295 Scores on a scale
Standard Deviation 0.20956
0.0175 Scores on a scale
Standard Deviation 0.19186
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 41 Maintenance
0.0247 Scores on a scale
Standard Deviation 0.23996
0.0084 Scores on a scale
Standard Deviation 0.22003
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 47 Maintenance
0.0251 Scores on a scale
Standard Deviation 0.20478
0.0263 Scores on a scale
Standard Deviation 0.19109
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 53 Maintenance
0.0285 Scores on a scale
Standard Deviation 0.17721
-0.0270 Scores on a scale
Standard Deviation 0.20412
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 59 Maintenance
0.0156 Scores on a scale
Standard Deviation 0.11589
-0.0210 Scores on a scale
Standard Deviation 0.19579
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 65 Maintenance
0.0358 Scores on a scale
Standard Deviation 0.10770
-0.0302 Scores on a scale
Standard Deviation 0.20843
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 71 Maintenance
0.0604 Scores on a scale
Standard Deviation 0.08941
0.0165 Scores on a scale
Standard Deviation 0.11503
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 77 Maintenance
0.0783 Scores on a scale
Standard Deviation 0.06087
0.0193 Scores on a scale
Standard Deviation 0.20537
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 83 Maintenance
0.0200 Scores on a scale
Standard Deviation 0.09952
0.0720 Scores on a scale
Standard Deviation 0.08398
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Cycle 89 Maintenance
0.0640 Scores on a scale
Standard Deviation 0.09051
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, End of Treatment
-0.0251 Scores on a scale
Standard Deviation 0.22757
-0.0310 Scores on a scale
Standard Deviation 0.24320
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, Safety Follow-up
-0.0326 Scores on a scale
Standard Deviation 0.22131
-0.0460 Scores on a scale
Standard Deviation 0.23927
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU- EOT + 3 months
-0.0439 Scores on a scale
Standard Deviation 0.22896
-0.0222 Scores on a scale
Standard Deviation 0.22768
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 9 months
-0.0723 Scores on a scale
Standard Deviation 0.20713
-0.0400 Scores on a scale
Standard Deviation 0.23756
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 15 months
-0.0323 Scores on a scale
Standard Deviation 0.20492
-0.0386 Scores on a scale
Standard Deviation 0.22117
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 27 months
-0.0407 Scores on a scale
Standard Deviation 0.17664
-0.0635 Scores on a scale
Standard Deviation 0.23835
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 33 months
-0.0547 Scores on a scale
Standard Deviation 0.15663
-0.0114 Scores on a scale
Standard Deviation 0.23974
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 39 months
-0.0374 Scores on a scale
Standard Deviation 0.11831
-0.0993 Scores on a scale
Standard Deviation 0.24071
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 45 months
-0.0568 Scores on a scale
Standard Deviation 0.14026
-0.0648 Scores on a scale
Standard Deviation 0.23505
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 51 months
0.0000 Scores on a scale
Standard Deviation NA
Standard deviation is not applicable as only a single participant was analyzed.
0.0028 Scores on a scale
Standard Deviation 0.18532
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 57 months
-0.0780 Scores on a scale
Standard Deviation 0.11031
0.0000 Scores on a scale
Standard Deviation NA
Standard deviation is not applicable as only a single participant was analyzed.
Change From Baseline (CFB) for the Visual Analogue Score (VAS) and Health Utility Index (HUI) of European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Questionnaire
HUI, LTFU-EOT + 63 months
0.0000 Scores on a scale
Standard Deviation NA
Standard deviation is not applicable as only a single participant was analyzed.

SECONDARY outcome

Timeframe: Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)

Population: ITT Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=336 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=666 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 4 Chemotherapy · Stable
196 Participants
373 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 6 Chemotherapy · Stable
135 Participants
301 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 6 Chemotherapy · Worsened
34 Participants
78 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 1 Maintenance · Worsened
50 Participants
135 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 1 Maintenance · Stable
178 Participants
317 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 2 Maintenance · Worsened
58 Participants
139 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 2 Maintenance · Improved
60 Participants
90 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 2 Maintenance · Stable
68 Participants
138 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 2 Maintenance · Improved
95 Participants
159 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 2 Maintenance · Worsened
34 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 2 Maintenance · Stable
155 Participants
277 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 2 Maintenance · Worsened
29 Participants
90 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 2 Maintenance · Improved
71 Participants
110 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 3 Maintenance · Stable
110 Participants
199 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 3 Maintenance · Worsened
49 Participants
130 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 3 Maintenance · Worsened
83 Participants
183 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 3 Maintenance · Stable
101 Participants
185 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 3 Maintenance · Stable
51 Participants
119 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 3 Maintenance · Worsened
58 Participants
133 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 3 Maintenance · Stable
171 Participants
327 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 6 Maintenance · Worsened
52 Participants
100 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 6 Maintenance · Improved
52 Participants
78 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 6 Maintenance · Improved
38 Participants
75 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 6 Maintenance · Improved
67 Participants
142 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 6 Maintenance · Improved
93 Participants
167 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 6 Maintenance · Improved
33 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 6 Maintenance · Improved
59 Participants
110 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 6 Maintenance · Improved
61 Participants
108 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 9 Maintenance · Stable
88 Participants
168 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 9 Maintenance · Stable
47 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 9 Maintenance · Improved
91 Participants
164 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 9 Maintenance · Worsened
35 Participants
65 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 9 Maintenance · Improved
41 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 53 Maintenance · Worsened
3 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 53 Maintenance · Improved
2 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 59 Maintenance · Stable
11 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 59 Maintenance · Improved
4 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 59 Maintenance · Stable
10 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 59 Maintenance · Improved
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 59 Maintenance · Stable
11 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 65 Maintenance · Worsened
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 77 Maintenance · Worsened
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 77 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 83 Maintenance · Stable
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 83 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 83 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 83 Maintenance · Stable
3 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 83 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 83 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 83 Maintenance · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 83 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 83 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 83 Maintenance · Improved
3 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 83 Maintenance · Worsened
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 83 Maintenance · Worsened
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 83 Maintenance · Improved
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 89 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, End of treatment (EOT) · Improved
53 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, EOT · Improved
59 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, EOT · Improved
62 Participants
125 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, EOT · Worsened
67 Participants
133 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, EOT · Stable
92 Participants
161 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, EOT · Improved
25 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 9 months) · Worsened
34 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 45 months) · Worsened
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 51 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 15 Maintenance · Stable
95 Participants
172 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 9 Maintenance · Improved
55 Participants
113 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 15 Maintenance · Improved
29 Participants
56 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 15 Maintenance · Worsened
37 Participants
65 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 15 Maintenance · Stable
73 Participants
128 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 9 Maintenance · Worsened
62 Participants
89 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 17 Maintenance · Worsened
8 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 9 Maintenance · Stable
83 Participants
189 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 9 Maintenance · Improved
44 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 9 Maintenance · Worsened
15 Participants
36 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 9 Maintenance · Stable
138 Participants
264 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 9 Maintenance · Improved
36 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 9 Maintenance · Worsened
18 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 9 Maintenance · Stable
145 Participants
276 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 9 Maintenance · Improved
27 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 12 Maintenance · Worsened
23 Participants
64 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 12 Maintenance · Stable
69 Participants
141 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 12 Maintenance · Improved
70 Participants
111 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 12 Maintenance · Worsened
22 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 12 Maintenance · Stable
82 Participants
167 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 12 Maintenance · Improved
57 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 12 Maintenance · Worsened
29 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 12 Maintenance · Stable
68 Participants
127 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 12 Maintenance · Improved
64 Participants
129 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 12 Maintenance · Worsened
31 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 12 Maintenance · Stable
82 Participants
181 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 12 Maintenance · Improved
49 Participants
65 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 12 Maintenance · Worsened
50 Participants
106 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 12 Maintenance · Stable
86 Participants
154 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 12 Maintenance · Improved
26 Participants
55 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 12 Maintenance · Worsened
27 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 12 Maintenance · Stable
69 Participants
123 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 12 Maintenance · Improved
66 Participants
117 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 12 Maintenance · Worsened
39 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 12 Maintenance · Stable
42 Participants
88 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 12 Maintenance · Improved
80 Participants
140 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 12 Maintenance · Worsened
21 Participants
62 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 12 Maintenance · Stable
105 Participants
190 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 12 Maintenance · Improved
35 Participants
62 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 12 Maintenance · Worsened
33 Participants
100 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 12 Maintenance · Stable
71 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 12 Maintenance · Improved
58 Participants
119 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 12 Maintenance · Worsened
27 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 12 Maintenance · Stable
107 Participants
197 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 12 Maintenance · Improved
26 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 12 Maintenance · Worsened
28 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 12 Maintenance · Stable
80 Participants
161 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 12 Maintenance · Improved
53 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 12 Maintenance · Worsened
12 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 12 Maintenance · Stable
99 Participants
173 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 12 Maintenance · Improved
50 Participants
92 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 12 Maintenance · Worsened
38 Participants
90 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 12 Maintenance · Stable
79 Participants
150 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 12 Maintenance · Improved
44 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 12 Maintenance · Worsened
12 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 12 Maintenance · Stable
119 Participants
221 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 12 Maintenance · Improved
31 Participants
53 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 12 Maintenance · Worsened
17 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 12 Maintenance · Stable
126 Participants
222 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 12 Maintenance · Improved
19 Participants
50 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 15 Maintenance · Worsened
26 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 15 Maintenance · Stable
67 Participants
142 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 15 Maintenance · Improved
60 Participants
85 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 15 Maintenance · Worsened
24 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 15 Maintenance · Stable
67 Participants
137 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 15 Maintenance · Improved
60 Participants
85 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 15 Maintenance · Worsened
25 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 15 Maintenance · Stable
60 Participants
108 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 15 Maintenance · Improved
68 Participants
118 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 15 Maintenance · Worsened
37 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 15 Maintenance · Stable
78 Participants
160 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 15 Maintenance · Improved
37 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 15 Maintenance · Worsened
54 Participants
111 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 15 Maintenance · Stable
78 Participants
120 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 15 Maintenance · Improved
21 Participants
56 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 15 Maintenance · Worsened
27 Participants
61 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 15 Maintenance · Stable
70 Participants
121 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 15 Maintenance · Improved
56 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 15 Maintenance · Worsened
38 Participants
81 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 15 Maintenance · Stable
40 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 15 Maintenance · Improved
75 Participants
132 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 15 Maintenance · Worsened
29 Participants
47 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 15 Maintenance · Stable
92 Participants
179 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 15 Maintenance · Improved
32 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 15 Maintenance · Worsened
38 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 15 Maintenance · Stable
58 Participants
102 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 4 Chemotherapy · Worsened
70 Participants
148 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 4 Chemotherapy · Stable
142 Participants
283 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 4 Chemotherapy · Improved
71 Participants
116 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 4 Chemotherapy · Worsened
77 Participants
150 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 4 Chemotherapy · Stable
146 Participants
290 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 4 Chemotherapy · Improved
60 Participants
108 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 4 Chemotherapy · Worsened
95 Participants
183 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 4 Chemotherapy · Stable
104 Participants
207 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 4 Chemotherapy · Improved
84 Participants
157 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 4 Chemotherapy · Worsened
46 Participants
128 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 4 Chemotherapy · Stable
179 Participants
317 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 4 Chemotherapy · Improved
58 Participants
103 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 4 Chemotherapy · Worsened
93 Participants
174 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 4 Chemotherapy · Stable
149 Participants
272 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 4 Chemotherapy · Improved
41 Participants
102 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 4 Chemotherapy · Worsened
95 Participants
201 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 4 Chemotherapy · Stable
120 Participants
220 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 4 Chemotherapy · Improved
67 Participants
127 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 4 Chemotherapy · Worsened
121 Participants
223 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 4 Chemotherapy · Stable
79 Participants
155 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 4 Chemotherapy · Improved
83 Participants
170 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 4 Chemotherapy · Worsened
47 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 4 Chemotherapy · Stable
191 Participants
363 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 4 Chemotherapy · Improved
45 Participants
94 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 4 Chemotherapy · Worsened
88 Participants
170 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 4 Chemotherapy · Stable
107 Participants
224 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 4 Chemotherapy · Improved
88 Participants
154 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 4 Chemotherapy · Worsened
59 Participants
103 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 4 Chemotherapy · Stable
179 Participants
346 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 4 Chemotherapy · Improved
45 Participants
99 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 4 Chemotherapy · Worsened
58 Participants
96 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 4 Chemotherapy · Stable
147 Participants
319 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 4 Chemotherapy · Improved
78 Participants
133 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 4 Chemotherapy · Worsened
53 Participants
111 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 4 Chemotherapy · Stable
163 Participants
322 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 4 Chemotherapy · Improved
67 Participants
115 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 4 Chemotherapy · Worsened
67 Participants
104 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 4 Chemotherapy · Stable
153 Participants
299 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 4 Chemotherapy · Improved
63 Participants
145 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 4 Chemotherapy · Worsened
41 Participants
82 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 4 Chemotherapy · Improved
46 Participants
93 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 4 Chemotherapy · Worsened
28 Participants
98 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 4 Chemotherapy · Stable
214 Participants
380 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 4 Chemotherapy · Improved
41 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 6 Chemotherapy · Worsened
66 Participants
147 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 6 Chemotherapy · Stable
133 Participants
260 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 6 Chemotherapy · Improved
74 Participants
147 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 6 Chemotherapy · Worsened
80 Participants
163 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 6 Chemotherapy · Stable
131 Participants
274 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 6 Chemotherapy · Improved
62 Participants
117 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 6 Chemotherapy · Worsened
78 Participants
195 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 6 Chemotherapy · Stable
104 Participants
189 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 6 Chemotherapy · Improved
91 Participants
169 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 6 Chemotherapy · Worsened
48 Participants
123 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 6 Chemotherapy · Stable
162 Participants
316 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 6 Chemotherapy · Improved
63 Participants
114 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 6 Chemotherapy · Worsened
92 Participants
199 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 6 Chemotherapy · Stable
144 Participants
260 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 6 Chemotherapy · Improved
37 Participants
94 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 6 Chemotherapy · Worsened
79 Participants
185 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 6 Chemotherapy · Stable
116 Participants
222 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 6 Chemotherapy · Improved
78 Participants
146 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 6 Chemotherapy · Worsened
110 Participants
221 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 6 Chemotherapy · Stable
71 Participants
163 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 6 Chemotherapy · Improved
92 Participants
170 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 6 Chemotherapy · Worsened
43 Participants
116 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 6 Chemotherapy · Stable
182 Participants
340 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 6 Chemotherapy · Improved
48 Participants
98 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 6 Chemotherapy · Worsened
76 Participants
150 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 6 Chemotherapy · Stable
99 Participants
220 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 6 Chemotherapy · Improved
98 Participants
184 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 6 Chemotherapy · Worsened
56 Participants
150 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 6 Chemotherapy · Stable
174 Participants
316 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 6 Chemotherapy · Improved
43 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 6 Chemotherapy · Worsened
54 Participants
110 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 6 Chemotherapy · Improved
84 Participants
142 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 6 Chemotherapy · Worsened
44 Participants
113 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 6 Chemotherapy · Stable
162 Participants
288 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 6 Chemotherapy · Improved
67 Participants
153 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 6 Chemotherapy · Worsened
51 Participants
117 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 6 Chemotherapy · Stable
148 Participants
300 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 6 Chemotherapy · Improved
73 Participants
136 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 6 Chemotherapy · Stable
193 Participants
388 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 6 Chemotherapy · Improved
46 Participants
88 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 6 Chemotherapy · Worsened
35 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 6 Chemotherapy · Stable
203 Participants
395 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 6 Chemotherapy · Improved
35 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 1 Maintenance · Stable
138 Participants
241 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 1 Maintenance · Improved
78 Participants
126 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 1 Maintenance · Worsened
62 Participants
130 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 1 Maintenance · Stable
127 Participants
255 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 1 Maintenance · Improved
76 Participants
119 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 1 Maintenance · Worsened
73 Participants
144 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 1 Maintenance · Stable
100 Participants
186 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 1 Maintenance · Improved
93 Participants
172 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 1 Maintenance · Worsened
55 Participants
127 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 1 Maintenance · Stable
150 Participants
283 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 1 Maintenance · Improved
61 Participants
94 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 1 Maintenance · Worsened
96 Participants
181 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 1 Maintenance · Stable
132 Participants
246 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 1 Maintenance · Improved
38 Participants
77 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 1 Maintenance · Worsened
83 Participants
154 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 1 Maintenance · Stable
109 Participants
224 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 1 Maintenance · Improved
74 Participants
126 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 1 Maintenance · Worsened
89 Participants
180 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 1 Maintenance · Stable
71 Participants
145 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 1 Maintenance · Improved
106 Participants
179 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 1 Maintenance · Worsened
35 Participants
90 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 1 Maintenance · Improved
53 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 1 Maintenance · Worsened
58 Participants
127 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 1 Maintenance · Stable
104 Participants
186 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 1 Maintenance · Improved
104 Participants
191 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 1 Maintenance · Worsened
64 Participants
109 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 1 Maintenance · Stable
159 Participants
297 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 1 Maintenance · Improved
43 Participants
95 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 1 Maintenance · Worsened
49 Participants
98 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 1 Maintenance · Stable
143 Participants
253 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 1 Maintenance · Improved
74 Participants
153 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 1 Maintenance · Worsened
40 Participants
86 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 1 Maintenance · Stable
154 Participants
285 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 1 Maintenance · Improved
72 Participants
132 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 1 Maintenance · Worsened
54 Participants
88 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 1 Maintenance · Stable
143 Participants
270 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 1 Maintenance · Improved
68 Participants
145 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 1 Maintenance · Worsened
28 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 1 Maintenance · Stable
189 Participants
338 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 1 Maintenance · Improved
49 Participants
76 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 1 Maintenance · Worsened
33 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 1 Maintenance · Stable
195 Participants
361 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 1 Maintenance · Improved
38 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 2 Maintenance · Worsened
47 Participants
118 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 2 Maintenance · Stable
110 Participants
211 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 2 Maintenance · Improved
74 Participants
117 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 2 Maintenance · Worsened
43 Participants
107 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 2 Maintenance · Stable
115 Participants
236 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 2 Maintenance · Improved
72 Participants
103 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 2 Maintenance · Stable
83 Participants
151 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 2 Maintenance · Improved
89 Participants
155 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 2 Maintenance · Worsened
37 Participants
103 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 2 Maintenance · Stable
134 Participants
253 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 2 Maintenance · Worsened
78 Participants
160 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 2 Maintenance · Stable
117 Participants
208 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 2 Maintenance · Improved
36 Participants
78 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 2 Maintenance · Worsened
63 Participants
137 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 2 Maintenance · Stable
91 Participants
177 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 2 Maintenance · Improved
77 Participants
132 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 2 Maintenance · Worsened
55 Participants
146 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 2 Maintenance · Improved
108 Participants
161 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 2 Maintenance · Worsened
42 Participants
94 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 2 Maintenance · Stable
144 Participants
266 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 2 Maintenance · Improved
45 Participants
85 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 2 Maintenance · Worsened
48 Participants
128 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 2 Maintenance · Stable
88 Participants
159 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 2 Maintenance · Improved
41 Participants
77 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 2 Maintenance · Worsened
41 Participants
90 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 2 Maintenance · Stable
115 Participants
220 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 2 Maintenance · Improved
75 Participants
135 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 2 Maintenance · Stable
134 Participants
250 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 2 Maintenance · Improved
67 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 2 Maintenance · Worsened
42 Participants
85 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 2 Maintenance · Stable
118 Participants
249 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 2 Maintenance · Worsened
22 Participants
52 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 2 Maintenance · Stable
160 Participants
315 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 2 Maintenance · Improved
49 Participants
79 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 2 Maintenance · Worsened
26 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 2 Maintenance · Stable
175 Participants
316 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 2 Maintenance · Improved
30 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 3 Maintenance · Worsened
56 Participants
146 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 3 Maintenance · Improved
76 Participants
112 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 3 Maintenance · Stable
113 Participants
216 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 3 Maintenance · Improved
79 Participants
109 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 3 Maintenance · Worsened
68 Participants
146 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 3 Maintenance · Stable
85 Participants
163 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 3 Maintenance · Improved
88 Participants
147 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 3 Maintenance · Worsened
60 Participants
122 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 3 Maintenance · Stable
126 Participants
255 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 3 Maintenance · Improved
56 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 3 Maintenance · Stable
120 Participants
193 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 3 Maintenance · Improved
39 Participants
81 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 3 Maintenance · Worsened
63 Participants
152 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 3 Maintenance · Improved
78 Participants
119 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 3 Maintenance · Worsened
84 Participants
182 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 3 Maintenance · Improved
106 Participants
156 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 3 Maintenance · Worsened
70 Participants
147 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 3 Maintenance · Stable
122 Participants
241 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 3 Maintenance · Improved
49 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 3 Maintenance · Stable
95 Participants
167 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 3 Maintenance · Improved
89 Participants
157 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 3 Maintenance · Worsened
65 Participants
121 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 3 Maintenance · Stable
136 Participants
258 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 3 Maintenance · Improved
39 Participants
77 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 3 Maintenance · Worsened
55 Participants
115 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 3 Maintenance · Stable
117 Participants
221 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 3 Maintenance · Improved
69 Participants
121 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 3 Maintenance · Worsened
45 Participants
124 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 3 Maintenance · Stable
129 Participants
229 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 3 Maintenance · Improved
66 Participants
104 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 3 Maintenance · Worsened
73 Participants
125 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 3 Maintenance · Stable
110 Participants
221 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 3 Maintenance · Improved
58 Participants
111 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 3 Maintenance · Worsened
15 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 3 Maintenance · Stable
177 Participants
329 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 9 Maintenance · Improved
77 Participants
126 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 3 Maintenance · Improved
50 Participants
90 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 3 Maintenance · Worsened
31 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 3 Maintenance · Improved
40 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 6 Maintenance · Worsened
30 Participants
89 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 6 Maintenance · Stable
101 Participants
192 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 6 Maintenance · Improved
70 Participants
129 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 6 Maintenance · Worsened
39 Participants
86 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 6 Maintenance · Stable
96 Participants
222 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 6 Maintenance · Improved
65 Participants
101 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 6 Maintenance · Stable
75 Participants
171 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 6 Maintenance · Improved
74 Participants
139 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 6 Maintenance · Worsened
36 Participants
86 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 6 Maintenance · Stable
113 Participants
246 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 6 Maintenance · Worsened
68 Participants
134 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 6 Maintenance · Stable
95 Participants
201 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 6 Maintenance · Worsened
43 Participants
106 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 6 Maintenance · Stable
91 Participants
162 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 6 Maintenance · Worsened
49 Participants
132 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 6 Maintenance · Stable
59 Participants
110 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 6 Maintenance · Worsened
36 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 6 Maintenance · Stable
126 Participants
247 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 6 Maintenance · Improved
39 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 6 Maintenance · Worsened
44 Participants
96 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 6 Maintenance · Stable
85 Participants
161 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 6 Maintenance · Improved
72 Participants
153 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 15 Maintenance · Improved
57 Participants
114 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 6 Maintenance · Worsened
43 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 6 Maintenance · Stable
125 Participants
240 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 6 Maintenance · Worsened
43 Participants
88 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 6 Maintenance · Stable
99 Participants
211 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 6 Maintenance · Worsened
29 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 6 Maintenance · Stable
111 Participants
232 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 6 Maintenance · Worsened
62 Participants
106 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 6 Maintenance · Stable
89 Participants
207 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 6 Maintenance · Improved
49 Participants
93 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 6 Maintenance · Worsened
8 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 6 Maintenance · Stable
152 Participants
293 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 6 Maintenance · Improved
41 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 6 Maintenance · Worsened
21 Participants
50 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 6 Maintenance · Stable
145 Participants
299 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 6 Maintenance · Improved
35 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 9 Maintenance · Worsened
22 Participants
76 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 9 Maintenance · Stable
100 Participants
167 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 9 Maintenance · Improved
68 Participants
127 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 9 Maintenance · Worsened
30 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 9 Maintenance · Stable
91 Participants
192 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 9 Maintenance · Improved
69 Participants
96 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 9 Maintenance · Worsened
41 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 9 Maintenance · Stable
71 Participants
140 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 9 Maintenance · Improved
78 Participants
145 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 9 Maintenance · Worsened
29 Participants
70 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 9 Maintenance · Stable
105 Participants
220 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 9 Maintenance · Improved
56 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 9 Maintenance · Worsened
57 Participants
113 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 9 Maintenance · Stable
102 Participants
183 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 9 Maintenance · Improved
31 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 9 Maintenance · Worsened
37 Participants
82 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 9 Maintenance · Improved
65 Participants
120 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 9 Maintenance · Worsened
52 Participants
101 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 9 Maintenance · Stable
114 Participants
234 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 9 Maintenance · Worsened
36 Participants
99 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 9 Maintenance · Stable
77 Participants
145 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 9 Maintenance · Worsened
37 Participants
73 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 9 Maintenance · Stable
119 Participants
223 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 9 Maintenance · Improved
34 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 9 Maintenance · Worsened
46 Participants
73 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 9 Maintenance · Stable
81 Participants
184 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 9 Maintenance · Improved
63 Participants
112 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 9 Maintenance · Worsened
14 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 15 Maintenance · Worsened
28 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 9 Maintenance · Stable
121 Participants
199 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 15 Maintenance · Improved
43 Participants
93 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 15 Maintenance · Worsened
13 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 15 Maintenance · Stable
89 Participants
164 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 15 Maintenance · Improved
50 Participants
92 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 15 Maintenance · Worsened
38 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 15 Maintenance · Stable
76 Participants
147 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 15 Maintenance · Improved
39 Participants
73 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 15 Maintenance · Worsened
12 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 15 Maintenance · Stable
116 Participants
200 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 15 Maintenance · Improved
25 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 15 Maintenance · Worsened
16 Participants
47 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 15 Maintenance · Stable
116 Participants
195 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 15 Maintenance · Improved
20 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 17 Maintenance · Worsened
4 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 17 Maintenance · Stable
24 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 17 Maintenance · Improved
12 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 17 Maintenance · Worsened
7 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 17 Maintenance · Stable
20 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 17 Maintenance · Improved
13 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 17 Maintenance · Worsened
10 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 17 Maintenance · Stable
14 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 17 Maintenance · Improved
16 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 17 Maintenance · Worsened
4 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 17 Maintenance · Stable
20 Participants
50 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 17 Maintenance · Improved
16 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 17 Maintenance · Worsened
13 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 17 Maintenance · Stable
21 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 17 Maintenance · Improved
6 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 17 Maintenance · Worsened
6 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 17 Maintenance · Stable
20 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 17 Maintenance · Improved
14 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 17 Maintenance · Worsened
6 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 17 Maintenance · Stable
14 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 17 Maintenance · Improved
20 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 17 Maintenance · Worsened
8 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 17 Maintenance · Stable
22 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 17 Maintenance · Improved
10 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 17 Maintenance · Worsened
8 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 17 Maintenance · Stable
13 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 17 Maintenance · Improved
19 Participants
36 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 17 Maintenance · Worsened
6 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 17 Maintenance · Stable
25 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 17 Maintenance · Improved
9 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 47 Maintenance · Stable
29 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 47 Maintenance · Improved
15 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 47 Maintenance · Worsened
18 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 47 Maintenance · Stable
24 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 47 Maintenance · Improved
6 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 47 Maintenance · Worsened
5 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 47 Maintenance · Stable
27 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 47 Maintenance · Improved
16 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 47 Maintenance · Worsened
7 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 47 Maintenance · Stable
11 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 47 Maintenance · Improved
30 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 47 Maintenance · Worsened
9 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 47 Maintenance · Stable
32 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 47 Maintenance · Improved
7 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 47 Maintenance · Worsened
11 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 47 Maintenance · Stable
18 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 47 Maintenance · Improved
19 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 47 Maintenance · Worsened
6 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 47 Maintenance · Stable
34 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 47 Maintenance · Improved
8 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 47 Maintenance · Worsened
11 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 47 Maintenance · Stable
23 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 47 Maintenance · Improved
14 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 47 Maintenance · Worsened
2 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 47 Maintenance · Stable
37 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 47 Maintenance · Improved
9 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 47 Maintenance · Worsened
13 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 47 Maintenance · Stable
25 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 47 Maintenance · Improved
10 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 47 Maintenance · Worsened
6 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 47 Maintenance · Stable
35 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 47 Maintenance · Improved
7 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 47 Maintenance · Worsened
6 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 47 Maintenance · Stable
37 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 47 Maintenance · Improved
5 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 53 Maintenance · Worsened
3 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 53 Maintenance · Stable
11 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 53 Maintenance · Improved
12 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 53 Maintenance · Worsened
4 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 53 Maintenance · Stable
11 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 53 Maintenance · Improved
11 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 53 Maintenance · Worsened
5 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 53 Maintenance · Stable
11 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 53 Maintenance · Improved
10 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 53 Maintenance · Worsened
3 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 53 Maintenance · Stable
17 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 53 Maintenance · Improved
6 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 53 Maintenance · Worsened
10 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 53 Maintenance · Stable
13 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 53 Maintenance · Improved
3 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 53 Maintenance · Worsened
7 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 53 Maintenance · Stable
12 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 53 Maintenance · Improved
7 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 53 Maintenance · Stable
7 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 53 Maintenance · Improved
16 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 17 Maintenance · Stable
19 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 17 Maintenance · Improved
13 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 17 Maintenance · Worsened
6 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 17 Maintenance · Stable
27 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 17 Maintenance · Improved
7 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 17 Maintenance · Worsened
6 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 17 Maintenance · Stable
22 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 17 Maintenance · Improved
12 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 17 Maintenance · Worsened
7 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 17 Maintenance · Stable
24 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 17 Maintenance · Improved
9 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 17 Maintenance · Worsened
7 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 17 Maintenance · Stable
26 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 17 Maintenance · Improved
7 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 23 Maintenance · Worsened
9 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 23 Maintenance · Stable
27 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 23 Maintenance · Improved
19 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 23 Maintenance · Worsened
10 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 23 Maintenance · Stable
29 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 23 Maintenance · Improved
16 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 23 Maintenance · Worsened
12 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 23 Maintenance · Stable
23 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 23 Maintenance · Improved
20 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 23 Maintenance · Worsened
10 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 23 Maintenance · Stable
33 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 23 Maintenance · Improved
12 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 23 Maintenance · Worsened
15 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 23 Maintenance · Stable
28 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 23 Maintenance · Improved
12 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 23 Maintenance · Worsened
12 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 23 Maintenance · Stable
31 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 23 Maintenance · Improved
12 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 23 Maintenance · Worsened
10 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 23 Maintenance · Stable
15 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 23 Maintenance · Improved
30 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 23 Maintenance · Worsened
8 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 23 Maintenance · Stable
36 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 23 Maintenance · Improved
11 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 23 Maintenance · Worsened
13 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 23 Maintenance · Stable
19 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 23 Maintenance · Improved
23 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 23 Maintenance · Worsened
7 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 23 Maintenance · Stable
37 Participants
62 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 23 Maintenance · Improved
11 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 23 Maintenance · Worsened
10 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 23 Maintenance · Stable
27 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 23 Maintenance · Improved
18 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 23 Maintenance · Worsened
6 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 23 Maintenance · Stable
40 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 23 Maintenance · Improved
9 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 23 Maintenance · Worsened
8 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 23 Maintenance · Stable
34 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 23 Maintenance · Improved
13 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 23 Maintenance · Worsened
4 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 23 Maintenance · Stable
41 Participants
70 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 23 Maintenance · Improved
10 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 23 Maintenance · Worsened
7 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 23 Maintenance · Stable
42 Participants
65 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 23 Maintenance · Improved
6 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 29 Maintenance · Worsened
5 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 29 Maintenance · Stable
27 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 29 Maintenance · Improved
20 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 29 Maintenance 20 · Worsened
4 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 29 Maintenance 20 · Stable
29 Participants
50 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 29 Maintenance 20 · Improved
19 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 29 Maintenance · Worsened
5 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 29 Maintenance · Stable
22 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 29 Maintenance · Improved
25 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 29 Maintenance · Worsened
5 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 29 Maintenance · Stable
32 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 29 Maintenance · Improved
15 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 29 Maintenance · Worsened
11 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 29 Maintenance · Stable
29 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 29 Maintenance · Improved
12 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 29 Maintenance · Worsened
12 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 29 Maintenance · Stable
20 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 29 Maintenance · Improved
20 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 29 Maintenance · Worsened
10 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 29 Maintenance · Stable
17 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 29 Maintenance · Improved
25 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 29 Maintenance · Worsened
4 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 29 Maintenance · Stable
37 Participants
64 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 29 Maintenance · Improved
11 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 29 Maintenance · Worsened
10 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 29 Maintenance · Stable
20 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 29 Maintenance · Improved
21 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 29 Maintenance · Worsened
9 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 29 Maintenance · Stable
30 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 29 Maintenance · Improved
12 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 29 Maintenance · Worsened
14 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 29 Maintenance · Stable
24 Participants
47 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 29 Maintenance · Improved
14 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 29 Maintenance · Worsened
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 29 Maintenance · Stable
37 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 29 Maintenance · Improved
11 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 29 Maintenance · Worsened
5 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 29 Maintenance · Stable
29 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 29 Maintenance · Improved
18 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 29 Maintenance · Worsened
3 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 29 Maintenance · Stable
39 Participants
76 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 29 Maintenance · Improved
10 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 29 Maintenance · Worsened
2 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 29 Maintenance · Stable
42 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 29 Maintenance · Improved
8 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 35 Maintenance · Worsened
4 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 35 Maintenance · Stable
24 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 35 Maintenance · Improved
16 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 35 Maintenance · Worsened
9 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 35 Maintenance · Stable
19 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 35 Maintenance · Improved
16 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 35 Maintenance · Worsened
6 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 35 Maintenance · Stable
21 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 35 Maintenance · Improved
17 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 35 Maintenance · Worsened
8 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 35 Maintenance · Stable
24 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 35 Maintenance · Improved
12 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 35 Maintenance · Worsened
15 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 35 Maintenance · Stable
23 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 35 Maintenance · Improved
6 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 35 Maintenance · Worsened
11 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 35 Maintenance · Stable
21 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 35 Maintenance · Improved
12 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 35 Maintenance · Worsened
10 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 35 Maintenance · Stable
10 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 35 Maintenance · Improved
24 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 35 Maintenance · Worsened
6 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 35 Maintenance · Stable
33 Participants
53 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 35 Maintenance · Improved
5 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 35 Maintenance · Worsened
6 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 35 Maintenance · Stable
19 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 35 Maintenance · Improved
19 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 35 Maintenance · Worsened
8 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 35 Maintenance · Stable
30 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 35 Maintenance · Improved
6 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 35 Maintenance · Worsened
15 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 35 Maintenance · Stable
20 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 35 Maintenance · Improved
9 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 35 Maintenance · Worsened
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 35 Maintenance · Stable
36 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 35 Maintenance · Improved
5 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 35 Maintenance · Worsened
5 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 35 Maintenance · Stable
27 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 35 Maintenance · Improved
12 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 53 Maintenance · Worsened
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 35 Maintenance · Worsened
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 35 Maintenance · Stable
35 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 35 Maintenance · Improved
5 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 35 Maintenance · Worsened
6 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 35 Maintenance · Stable
30 Participants
53 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 35 Maintenance · Improved
8 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 41 Maintenance · Worsened
10 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 53 Maintenance · Stable
19 Participants
36 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 41 Maintenance · Stable
26 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 41 Maintenance · Improved
22 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 41 Maintenance · Worsened
5 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 41 Maintenance · Stable
32 Participants
54 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 41 Maintenance · Improved
21 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 41 Maintenance · Worsened
9 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 41 Maintenance · Stable
25 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 41 Maintenance · Improved
24 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 41 Maintenance · Worsened
10 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 53 Maintenance · Improved
4 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 53 Maintenance · Worsened
4 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 89 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 41 Maintenance · Stable
35 Participants
55 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 41 Maintenance · Improved
13 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 41 Maintenance · Worsened
23 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 41 Maintenance · Stable
25 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 53 Maintenance · Stable
12 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 53 Maintenance · Improved
10 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 41 Maintenance · Improved
10 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 53 Maintenance · Worsened
3 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 41 Maintenance · Worsened
13 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 41 Maintenance · Stable
25 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 41 Maintenance · Improved
20 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 41 Maintenance · Worsened
11 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 41 Maintenance · Stable
17 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 53 Maintenance · Stable
18 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 41 Maintenance · Improved
30 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 41 Maintenance · Worsened
8 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 41 Maintenance · Stable
39 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 41 Maintenance · Improved
11 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 41 Maintenance · Worsened
11 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 41 Maintenance · Stable
23 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 53 Maintenance · Improved
5 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 53 Maintenance · Worsened
8 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 53 Maintenance · Stable
13 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 41 Maintenance · Improved
24 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 41 Maintenance · Worsened
8 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 41 Maintenance · Stable
39 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 41 Maintenance · Improved
11 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 41 Maintenance · Worsened
16 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 53 Maintenance · Improved
5 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 53 Maintenance · Worsened
2 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 53 Maintenance · Stable
22 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 41 Maintenance · Stable
25 Participants
52 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 41 Maintenance · Improved
17 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 41 Maintenance · Worsened
9 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 41 Maintenance · Stable
38 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 41 Maintenance · Improved
11 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 41 Maintenance · Worsened
12 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 53 Maintenance · Worsened
7 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 53 Maintenance · Stable
14 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 53 Maintenance · Improved
5 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 41 Maintenance · Stable
33 Participants
47 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 41 Maintenance · Improved
13 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 41 Maintenance · Worsened
5 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 53 Maintenance · Worsened
2 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 41 Maintenance · Stable
44 Participants
85 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 53 Maintenance · Stable
20 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 53 Maintenance · Improved
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 53 Maintenance · Worsened
6 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 53 Maintenance · Stable
16 Participants
36 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 53 Maintenance · Improved
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 59 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 59 Maintenance · Improved
6 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 59 Maintenance · Worsened
3 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 59 Maintenance · Stable
8 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 59 Maintenance · Improved
7 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 59 Maintenance · Worsened
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 59 Maintenance · Stable
8 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 59 Maintenance · Improved
7 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 59 Maintenance · Worsened
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 59 Maintenance · Stable
11 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 59 Maintenance · Improved
3 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 59 Maintenance · Worsened
5 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 59 Maintenance · Stable
11 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 41 Maintenance · Improved
9 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 41 Maintenance · Worsened
8 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 41 Maintenance · Stable
42 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 41 Maintenance · Improved
8 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 47 Maintenance · Worsened
5 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 47 Maintenance · Stable
26 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 47 Maintenance · Improved
17 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 47 Maintenance · Worsened
4 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 47 Maintenance · Stable
30 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 47 Maintenance · Improved
14 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 47 Maintenance · Worsened
8 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 47 Maintenance · Stable
23 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 47 Maintenance · Improved
17 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 47 Maintenance · Worsened
4 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 59 Maintenance · Improved
2 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 59 Maintenance · Worsened
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 59 Maintenance · Stable
10 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 59 Maintenance · Worsened
4 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 59 Maintenance · Stable
8 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 59 Maintenance · Improved
6 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 59 Maintenance · Worsened
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 59 Maintenance · Stable
12 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 59 Maintenance · Improved
2 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 59 Maintenance · Worsened
1 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 59 Maintenance · Improved
7 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 59 Maintenance · Worsened
2 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 59 Maintenance · Stable
12 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 59 Maintenance · Improved
4 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 59 Maintenance · Worsened
6 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 59 Maintenance · Stable
10 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 59 Maintenance · Improved
2 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 59 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 59 Maintenance · Stable
16 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 59 Maintenance · Improved
1 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 59 Maintenance · Worsened
5 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 59 Maintenance · Stable
12 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 59 Maintenance · Improved
1 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 59 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 59 Maintenance · Stable
14 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 59 Maintenance · Worsened
3 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 59 Maintenance · Improved
4 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 65 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 65 Maintenance · Stable
7 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 65 Maintenance · Improved
4 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 65 Maintenance · Worsened
1 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 65 Maintenance · Stable
6 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 65 Maintenance · Improved
5 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 65 Maintenance · Worsened
2 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 65 Maintenance · Stable
4 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 65 Maintenance · Improved
6 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 65 Maintenance · Worsened
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 65 Maintenance · Stable
8 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 65 Maintenance · Improved
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 65 Maintenance · Worsened
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 65 Maintenance · Stable
7 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 65 Maintenance · Improved
2 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 65 Maintenance · Stable
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 65 Maintenance · Improved
4 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 65 Maintenance · Worsened
1 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 65 Maintenance · Stable
5 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 65 Maintenance · Improved
6 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 65 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 65 Maintenance · Stable
9 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 65 Maintenance · Improved
2 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 65 Maintenance · Worsened
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 65 Maintenance · Stable
7 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 65 Maintenance · Improved
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 65 Maintenance · Worsened
2 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 65 Maintenance · Stable
9 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 65 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 65 Maintenance · Worsened
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 65 Maintenance · Stable
7 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 65 Maintenance · Improved
2 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 65 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 65 Maintenance · Stable
11 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 65 Maintenance · Improved
1 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 65 Maintenance · Worsened
6 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 65 Maintenance · Stable
5 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 65 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 65 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 65 Maintenance · Stable
10 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 65 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 65 Maintenance · Worsened
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 65 Maintenance · Stable
8 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 65 Maintenance · Improved
3 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 71 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 71 Maintenance · Stable
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 71 Maintenance · Improved
5 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 71 Maintenance · Worsened
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 71 Maintenance · Stable
4 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 71 Maintenance · Improved
3 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 71 Maintenance · Worsened
0 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 71 Maintenance · Stable
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 71 Maintenance · Improved
4 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 71 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 71 Maintenance · Stable
6 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 71 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 71 Maintenance · Worsened
3 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 71 Maintenance · Stable
5 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 71 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 71 Maintenance · Worsened
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 71 Maintenance · Stable
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 71 Maintenance · Improved
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 71 Maintenance · Worsened
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 71 Maintenance · Stable
3 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 71 Maintenance · Improved
5 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 71 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 71 Maintenance · Stable
5 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 71 Maintenance · Improved
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 71 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 71 Maintenance · Stable
4 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 71 Maintenance · Improved
4 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 71 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 71 Maintenance · Stable
7 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 71 Maintenance · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 71 Maintenance · Worsened
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 71 Maintenance · Stable
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 71 Maintenance · Improved
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 71 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 71 Maintenance · Stable
6 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 71 Maintenance · Improved
2 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 71 Maintenance · Worsened
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 71 Maintenance · Stable
4 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 71 Maintenance · Improved
2 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 71 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 71 Maintenance · Stable
7 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 71 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 71 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 71 Maintenance · Stable
4 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 71 Maintenance · Improved
3 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 77 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 77 Maintenance · Stable
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 77 Maintenance · Improved
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 77 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 77 Maintenance · Stable
2 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 77 Maintenance · Improved
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 77 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 77 Maintenance · Stable
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 77 Maintenance · Improved
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 77 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 77 Maintenance · Stable
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 77 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 77 Maintenance · Stable
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 77 Maintenance · Improved
1 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 77 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 77 Maintenance · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 77 Maintenance · Improved
2 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 77 Maintenance · Worsened
0 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 77 Maintenance · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 77 Maintenance · Improved
3 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 77 Maintenance · Stable
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 77 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 77 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 77 Maintenance · Stable
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 77 Maintenance · Improved
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 77 Maintenance · Worsened
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 77 Maintenance · Stable
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 77 Maintenance · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 77 Maintenance · Worsened
0 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 77 Maintenance · Stable
3 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 77 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 77 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 77 Maintenance · Stable
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 77 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 77 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 77 Maintenance · Stable
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 77 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 77 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 77 Maintenance · Stable
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 77 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 77 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 77 Maintenance · Stable
2 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 77 Maintenance · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 83 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 83 Maintenance · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 83 Maintenance · Improved
2 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 83 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 83 Maintenance · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 83 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 83 Maintenance · Stable
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 83 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 83 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 83 Maintenance · Stable
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 83 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 83 Maintenance · Stable
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 83 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 83 Maintenance · Stable
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 83 Maintenance · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 83 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 83 Maintenance · Stable
3 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 83 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 83 Maintenance · Stable
3 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 83 Maintenance · Worsened
2 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 83 Maintenance · Stable
0 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 83 Maintenance · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 83 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 83 Maintenance · Stable
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 83 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 83 Maintenance · Worsened
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 83 Maintenance · Stable
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 83 Maintenance · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Cycle 89 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 89 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 89 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, End of treatment (EOT) · Worsened
50 Participants
111 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, End of treatment (EOT) · Stable
81 Participants
150 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, EOT · Worsened
44 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, EOT · Stable
80 Participants
161 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, EOT · Worsened
57 Participants
102 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, EOT · Stable
64 Participants
115 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, EOT · Worsened
68 Participants
127 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, EOT · Stable
92 Participants
155 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, EOT · Improved
24 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, EOT · Worsened
58 Participants
119 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, EOT · Stable
68 Participants
118 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, EOT · Improved
58 Participants
108 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, EOT · Worsened
66 Participants
124 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, EOT · Stable
45 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, EOT · Improved
73 Participants
140 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, EOT · Worsened
38 Participants
72 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, EOT · Stable
117 Participants
204 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, EOT · Improved
29 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, EOT · Worsened
66 Participants
95 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, EOT · Stable
50 Participants
140 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, EOT · Improved
68 Participants
110 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, EOT · Worsened
47 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, EOT · Stable
109 Participants
185 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, EOT · Improved
28 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, EOT · Worsened
47 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, EOT · Stable
81 Participants
160 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, EOT · Improved
56 Participants
93 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, EOT · Worsened
40 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, EOT · Stable
94 Participants
188 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, EOT · Improved
49 Participants
81 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, EOT · Worsened
44 Participants
73 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, EOT · Stable
89 Participants
172 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, EOT · Improved
50 Participants
98 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, EOT · Worsened
24 Participants
61 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, EOT · Stable
127 Participants
225 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, EOT · Improved
33 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, EOT · Worsened
28 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, EOT · Stable
130 Participants
239 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, EOT · Improved
25 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Safety Follow-up · Worsened
36 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Safety Follow-up · Stable
71 Participants
130 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, Safety Follow-up · Improved
39 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Safety Follow-up · Worsened
40 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Safety Follow-up · Stable
66 Participants
129 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, Safety Follow-up · Improved
40 Participants
78 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Safety Follow-up · Worsened
46 Participants
99 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Safety Follow-up · Stable
55 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, Safety Follow-up · Improved
45 Participants
102 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Safety Follow-up · Worsened
44 Participants
107 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Safety Follow-up · Stable
72 Participants
147 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, Safety Follow-up · Improved
30 Participants
36 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Safety Follow-up · Worsened
56 Participants
112 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Safety Follow-up · Stable
69 Participants
119 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, Safety Follow-up · Improved
21 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Safety Follow-up · Worsened
42 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Safety Follow-up · Stable
59 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, Safety Follow-up · Improved
45 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Safety Follow-up · Worsened
54 Participants
109 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Safety Follow-up · Stable
31 Participants
75 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, Safety Follow-up · Improved
61 Participants
106 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Safety Follow-up · Worsened
34 Participants
65 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Safety Follow-up · Stable
92 Participants
169 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, Safety Follow-up · Improved
20 Participants
56 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Safety Follow-up · Worsened
50 Participants
108 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Safety Follow-up · Stable
47 Participants
101 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, Safety Follow-up · Improved
49 Participants
81 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Safety Follow-up · Worsened
36 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Safety Follow-up · Stable
91 Participants
158 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, Safety Follow-up · Improved
19 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Safety Follow-up · Worsened
22 Participants
79 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Safety Follow-up · Stable
75 Participants
132 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, Safety Follow-up · Improved
49 Participants
79 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Safety Follow-up · Worsened
28 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Safety Follow-up · Stable
81 Participants
140 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, Safety Follow-up · Improved
37 Participants
75 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Safety Follow-up · Worsened
32 Participants
56 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Safety Follow-up · Stable
72 Participants
153 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, Safety Follow-up · Improved
41 Participants
81 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Safety Follow-up · Worsened
21 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Safety Follow-up · Stable
97 Participants
184 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, Safety Follow-up · Improved
27 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Safety Follow-up · Worsened
19 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Safety Follow-up · Stable
114 Participants
199 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, Safety Follow-up · Improved
12 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 3 months) · Worsened
39 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 3 months) · Stable
53 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 3 months) · Improved
43 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 3 months) · Worsened
42 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 3 months) · Stable
66 Participants
100 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 3 months) · Improved
27 Participants
70 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 3 months) · Worsened
52 Participants
70 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 3 months) · Stable
42 Participants
84 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 3 months) · Improved
41 Participants
95 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 3 months) · Worsened
30 Participants
76 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 3 months) · Stable
76 Participants
129 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 3 months) · Improved
29 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 3 months) · Worsened
55 Participants
96 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 3 months) · Stable
64 Participants
110 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 3 months) · Improved
16 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 3 months) · Worsened
48 Participants
80 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 3 months) · Stable
51 Participants
91 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 3 months) · Improved
36 Participants
79 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 3 months) · Worsened
52 Participants
98 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 3 months) · Stable
28 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 3 months) · Improved
55 Participants
94 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 3 months) · Worsened
20 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 3 months) · Stable
88 Participants
155 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 3 months) · Improved
27 Participants
50 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 3 months) · Worsened
41 Participants
89 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 3 months) · Stable
42 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 3 months) · Improved
52 Participants
74 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 3 months) · Worsened
33 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 3 months) · Stable
84 Participants
141 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 3 months) · Improved
18 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 3 months) · Worsened
28 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 3 months) · Stable
66 Participants
111 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 3 months) · Improved
40 Participants
81 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 3 months) · Worsened
25 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 3 months) · Stable
75 Participants
130 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 3 months) · Improved
35 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 3 months) · Worsened
25 Participants
53 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 3 months) · Stable
64 Participants
128 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 3 months) · Improved
45 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 3 months) · Worsened
20 Participants
52 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 3 months) · Stable
89 Participants
157 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 3 months) · Improved
26 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 3 months) · Worsened
24 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 3 months) · Stable
90 Participants
169 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 3 months) · Improved
21 Participants
38 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 9 months) · Worsened
24 Participants
60 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 9 months) · Stable
53 Participants
77 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 9 months) · Improved
29 Participants
47 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 9 months) · Worsened
32 Participants
56 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 9 months) · Stable
59 Participants
83 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 9 months) · Improved
14 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 9 months) · Worsened
37 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 9 months) · Stable
37 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 9 months) · Improved
32 Participants
62 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 9 months) · Worsened
31 Participants
53 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 9 months) · Stable
57 Participants
97 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 9 months) · Improved
18 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 9 months) · Worsened
42 Participants
65 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 9 months) · Stable
55 Participants
89 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 9 months) · Improved
9 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 9 months) · Worsened
40 Participants
62 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 9 months) · Stable
37 Participants
69 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 9 months) · Improved
29 Participants
53 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 9 months) · Worsened
43 Participants
73 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 9 months) · Stable
22 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 9 months) · Improved
41 Participants
64 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 9 months) · Worsened
21 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 9 months) · Stable
68 Participants
112 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 9 months) · Improved
17 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 9 months) · Worsened
33 Participants
70 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 9 months) · Stable
46 Participants
59 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 9 months) · Improved
27 Participants
55 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 9 months) · Stable
59 Participants
103 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 9 months) · Improved
13 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 9 months) · Worsened
24 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 9 months) · Stable
55 Participants
82 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 9 months) · Improved
27 Participants
57 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 9 months) · Worsened
21 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 9 months) · Stable
59 Participants
93 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 9 months) · Improved
25 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 9 months) · Worsened
23 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 9 months) · Stable
50 Participants
85 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 9 months) · Improved
33 Participants
54 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 9 months) · Worsened
21 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 9 months) · Stable
65 Participants
122 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 9 months) · Improved
20 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 9 months) · Worsened
18 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 9 months) · Stable
67 Participants
129 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 9 months) · Improved
21 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 15 months) · Worsened
23 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 15 months) · Stable
34 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 15 months) · Improved
19 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 15 months) · Worsened
23 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 15 months) · Stable
38 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 15 months) · Improved
13 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 15 months) · Worsened
29 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 15 months) · Stable
22 Participants
66 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 15 months) · Improved
25 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 15 months) · Worsened
23 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 15 months) · Stable
42 Participants
86 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 15 months) · Improved
11 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 15 months) · Worsened
23 Participants
55 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 15 months) · Stable
43 Participants
70 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 15 months) · Improved
10 Participants
29 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 15 months) · Worsened
31 Participants
51 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 15 months) · Stable
23 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 15 months) · Improved
22 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 15 months) · Worsened
29 Participants
63 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 15 months) · Stable
14 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 15 months) · Improved
33 Participants
52 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 15 months) · Worsened
19 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 15 months) · Stable
49 Participants
101 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 15 months) · Improved
8 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 15 months) · Worsened
21 Participants
61 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 15 months) · Stable
30 Participants
54 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 15 months) · Improved
25 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 15 months) · Worsened
24 Participants
47 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 15 months) · Stable
43 Participants
82 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 15 months) · Improved
9 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 15 months) · Worsened
19 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 15 months) · Stable
32 Participants
71 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 15 months) · Improved
24 Participants
48 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 15 months) · Worsened
13 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 15 months) · Stable
40 Participants
87 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 15 months) · Improved
23 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 15 months) · Worsened
20 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 15 months) · Stable
35 Participants
73 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 15 months) · Improved
21 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 15 months) · Worsened
12 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 15 months) · Stable
52 Participants
103 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 15 months) · Improved
12 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 15 months) · Worsened
9 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 15 months) · Stable
54 Participants
105 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 15 months) · Improved
13 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 21 months) · Worsened
19 Participants
36 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 21 months) · Stable
14 Participants
37 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 21 months) · Improved
15 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 21 months) · Worsened
15 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 21 months) · Stable
25 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 21 months) · Improved
8 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 21 months) · Worsened
15 Participants
35 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 21 months) · Stable
16 Participants
30 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 21 months) · Improved
17 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 21 months) · Worsened
16 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 21 months) · Stable
28 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 21 months) · Improved
4 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 21 months) · Worsened
18 Participants
40 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 21 months) · Stable
24 Participants
39 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 21 months) · Improved
6 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 21 months) · Worsened
13 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 21 months) · Stable
20 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 21 months) · Improved
15 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 21 months) · Worsened
22 Participants
42 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 21 months) · Stable
9 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 21 months) · Improved
17 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 21 months) · Worsened
13 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 21 months) · Stable
28 Participants
61 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 21 months) · Improved
7 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 21 months) · Worsened
16 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 21 months) · Stable
14 Participants
34 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 21 months) · Improved
18 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 21 months) · Worsened
18 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 21 months) · Stable
24 Participants
58 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 21 months) · Improved
6 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 21 months) · Worsened
14 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 21 months) · Stable
22 Participants
41 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 21 months) · Improved
12 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 21 months) · Worsened
11 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 21 months) · Stable
24 Participants
56 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 21 months) · Improved
13 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 21 months) · Worsened
8 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 21 months) · Stable
22 Participants
45 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 21 months) · Improved
18 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 21 months) · Worsened
12 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 21 months) · Stable
32 Participants
62 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 21 months) · Improved
4 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 21 months) · Worsened
5 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 21 months) · Stable
33 Participants
68 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 21 months) · Improved
9 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 27 months) · Worsened
9 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 27 months) · Stable
15 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 27 months) · Improved
12 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 27 months) · Worsened
13 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 27 months) · Stable
16 Participants
32 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 27 months) · Improved
7 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 27 months) · Worsened
9 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 27 months) · Stable
13 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 27 months) · Improved
14 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 27 months) · Worsened
9 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 27 months) · Stable
21 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 27 months) · Improved
6 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 27 months) · Worsened
12 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 27 months) · Stable
16 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 27 months) · Improved
8 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 27 months) · Worsened
14 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 27 months) · Stable
11 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 27 months) · Improved
11 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 27 months) · Worsened
14 Participants
25 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 27 months) · Stable
7 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 27 months) · Improved
15 Participants
27 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 27 months) · Worsened
7 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 27 months) · Stable
25 Participants
46 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 27 months) · Improved
4 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 27 months) · Worsened
9 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 27 months) · Stable
13 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 27 months) · Improved
14 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 27 months) · Worsened
11 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 27 months) · Stable
19 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 27 months) · Improved
6 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 27 months) · Worsened
8 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 27 months) · Stable
18 Participants
31 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 27 months) · Improved
10 Participants
23 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 27 months) · Worsened
9 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 27 months) · Stable
16 Participants
44 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 27 months) · Improved
11 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 27 months) · Worsened
5 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 27 months) · Stable
17 Participants
33 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 27 months) · Improved
14 Participants
22 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 27 months) · Worsened
8 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 27 months) · Stable
25 Participants
43 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 27 months) · Improved
3 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 27 months) · Worsened
4 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 27 months) · Stable
25 Participants
49 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 27 months) · Improved
7 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 33 months) · Worsened
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 33 months) · Stable
6 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 33 months) · Improved
6 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 33 months) · Worsened
5 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 33 months) · Stable
9 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 33 months) · Improved
2 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 33 months) · Worsened
4 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 33 months) · Stable
8 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 33 months) · Improved
4 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 33 months) · Worsened
5 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 33 months) · Stable
8 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 33 months) · Improved
3 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 33 months) · Worsened
5 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 33 months) · Stable
9 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 33 months) · Improved
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 33 months) · Worsened
5 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 33 months) · Stable
6 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 33 months) · Improved
5 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 33 months) · Worsened
5 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 33 months) · Stable
2 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 33 months) · Improved
9 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 33 months) · Worsened
4 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 33 months) · Stable
11 Participants
24 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 33 months) · Improved
1 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 33 months) · Worsened
2 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 33 months) · Stable
7 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 33 months) · Improved
7 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 33 months) · Worsened
5 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 33 months) · Stable
9 Participants
21 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 33 months) · Improved
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 33 months) · Worsened
3 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 33 months) · Stable
9 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 33 months) · Improved
4 Participants
17 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 33 months) · Worsened
6 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 33 months) · Stable
7 Participants
28 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 33 months) · Improved
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 33 months) · Worsened
2 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 33 months) · Stable
7 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 33 months) · Improved
7 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 33 months) · Worsened
5 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 33 months) · Stable
10 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 33 months) · Improved
1 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 33 months) · Worsened
2 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 33 months) · Stable
10 Participants
26 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 33 months) · Improved
4 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 39 months) · Worsened
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 39 months) · Stable
3 Participants
14 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 39 months) · Improved
5 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 39 months) · Worsened
2 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 39 months) · Stable
6 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 39 months) · Improved
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 39 months) · Worsened
0 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 39 months) · Stable
7 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 39 months) · Improved
4 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 39 months) · Worsened
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 39 months) · Stable
7 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 39 months) · Improved
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 39 months) · Worsened
4 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 39 months) · Stable
5 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 39 months) · Improved
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 39 months) · Worsened
1 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 39 months) · Stable
4 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 39 months) · Improved
6 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 39 months) · Worsened
1 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 39 months) · Stable
3 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 39 months) · Improved
7 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 39 months) · Worsened
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 39 months) · Stable
8 Participants
19 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 39 months) · Improved
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 39 months) · Worsened
4 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 39 months) · Stable
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 39 months) · Improved
3 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 39 months) · Worsened
5 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 39 months) · Stable
3 Participants
15 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 39 months) · Improved
3 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 39 months) · Worsened
5 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 39 months) · Stable
3 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 39 months) · Improved
3 Participants
13 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 39 months) · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 39 months) · Stable
7 Participants
20 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 39 months) · Improved
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 39 months) · Worsened
2 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 39 months) · Stable
5 Participants
10 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 57 months) · Stable
2 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 57 months) · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 57 months) · Stable
2 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 57 months) · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 57 months) · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 57 months) · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 57 months) · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 57 months) · Stable
2 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 57 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 57 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 57 months) · Worsened
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 57 months) · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 57 months) · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 57 months) · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 57 months) · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 57 months) · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 57 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 57 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 57 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 57 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 57 months) · Stable
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 57 months) · Improved
2 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 63 months) · Stable
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 63 months) · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 63 months) · Stable
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 63 months) · Improved
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 51 months) · Stable
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 51 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 51 months) · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 51 months) · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 51 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 51 months) · Stable
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 51 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 51 months) · Stable
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 51 months) · Improved
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 57 months) · Stable
2 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 57 months) · Worsened
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 57 months) · Stable
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 57 months) · Stable
2 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 57 months) · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 39 months) · Improved
4 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 39 months) · Worsened
2 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 39 months) · Stable
8 Participants
16 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 39 months) · Improved
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 39 months) · Worsened
3 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 39 months) · Stable
6 Participants
18 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 39 months) · Improved
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 45 months) · Worsened
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 45 months) · Stable
1 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 45 months) · Improved
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 45 months) · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 45 months) · Stable
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 45 months) · Improved
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 45 months) · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 45 months) · Stable
4 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 45 months) · Improved
0 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 45 months) · Worsened
0 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 45 months) · Stable
3 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 45 months) · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 45 months) · Worsened
0 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 45 months) · Stable
4 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 45 months) · Improved
0 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 45 months) · Worsened
0 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 45 months) · Stable
2 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 45 months) · Improved
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 45 months) · Worsened
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 45 months) · Stable
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 45 months) · Improved
2 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 45 months) · Worsened
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 45 months) · Stable
4 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 45 months) · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 45 months) · Worsened
1 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 45 months) · Stable
1 Participants
6 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 45 months) · Improved
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 45 months) · Worsened
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 45 months) · Stable
2 Participants
9 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 45 months) · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 45 months) · Worsened
2 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 45 months) · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 45 months) · Improved
1 Participants
8 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 45 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 45 months) · Stable
2 Participants
12 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
AL, LTFU (EOT + 45 months) · Improved
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 45 months) · Stable
1 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Constipation, LTFU (EOT + 45 months) · Improved
2 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 45 months) · Worsened
0 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 45 months) · Stable
3 Participants
7 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Diarrhoea, LTFU (EOT + 45 months) · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 45 months) · Worsened
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 45 months) · Stable
1 Participants
11 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
FD, LTFU (EOT + 45 months) · Improved
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 51 months) · Stable
2 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
GHS/QoL, LTFU (EOT + 51 months) · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 51 months) · Worsened
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 51 months) · Stable
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
PF, LTFU (EOT + 51 months) · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 51 months) · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
RF, LTFU (EOT + 51 months) · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 51 months) · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
EF, LTFU (EOT + 51 months) · Improved
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 51 months) · Stable
2 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
CF, LTFU (EOT + 51 months) · Improved
0 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 51 months) · Stable
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
SF, LTFU (EOT + 51 months) · Improved
1 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 51 months) · Stable
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Fatigue, LTFU (EOT + 51 months) · Improved
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 51 months) · Stable
2 Participants
5 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
N/V, LTFU (EOT + 51 months) · Improved
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 51 months) · Stable
1 Participants
2 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Pain, LTFU (EOT + 51 months) · Improved
1 Participants
3 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 51 months) · Worsened
1 Participants
0 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 51 months) · Stable
1 Participants
4 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Dyspnoea, LTFU (EOT + 51 months) · Improved
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Improvement and Worsening in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Insomnia, LTFU (EOT + 51 months) · Stable
1 Participants
3 Participants

SECONDARY outcome

Timeframe: Day1 of Chemo Cycles 2(baseline), 4&6; Day1 of Maintenance Cycles 1,2,3,6,9,12,15,17,23,29,35,41,47,53,59,65,71,77,83,89; EOT visit up to a maximum of 63 months; LTFU visit up to a maximum of 69 months(including SFU visit up to a maximum of 61 months)

Population: ITT Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. As pre-specified in the protocol, the comparison of data was performed only between Arm 2 and Arm 3.

The EORTC QLQ-OV28 supplements the QLQ-C30. It includes three functional scales (body image (BI), sexuality (S), attitude to disease/treatment(ATD)) and five symptom scales/items (abdominal/GI symptoms (AS), peripheral neuropathy (PN), hormonal/menopausal symptoms (MS), other chemotherapy side effects (CSE), and hair loss (HS)). Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much). Higher scores represent better functioning (better quality of life). For functional scales: improved (worsened) is defined as \>=10 points increase (decrease) from baseline. For symptom scales: improved (worsened) is defined as \>=10 points decrease (increase) from baseline. Baseline is defined as the latest, non-missing collected value, excluding end of treatment, safety follow-up, long term follow-up visits records and unscheduled visits after end of treatment.

Outcome measures

Outcome measures
Measure
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=331 Participants
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=657 Participants
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 15 Maintenance · Stable
40 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 17 Maintenance · Stable
18 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 17 Maintenance · Stable
19 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 17 Maintenance · Improved
14 Participants
36 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 17 Maintenance · Worsened
19 Participants
45 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 29 Maintenance · Stable
30 Participants
54 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 47 Maintenance · Stable
18 Participants
34 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 47 Maintenance · Improved
15 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 45 months) · Worsened
3 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 45 months) · Stable
2 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 51 months) · Worsened
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 51 months) · Stable
2 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 51 months) · Improved
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 51 months) · Worsened
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 51 months) · Stable
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 51 months) · Improved
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 51 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 51 months) · Stable
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 57 months) · Stable
2 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 57 months) · Stable
2 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 57 months) · Worsened
2 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 57 months) · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 57 months) · Stable
2 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 57 months) · Improved
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 57 months) · Stable
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 57 months) · Improved
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 57 months) · Improved
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 63 months) · Worsened
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 33 months) · Stable
8 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 33 months) · Improved
6 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 4 Chemotherapy · Worsened
89 Participants
214 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 4 Chemotherapy · Stable
108 Participants
189 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 4 Chemotherapy · Improved
73 Participants
131 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 4 Chemotherapy · Worsened
30 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 4 Chemotherapy · Stable
188 Participants
390 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 4 Chemotherapy · Improved
51 Participants
77 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 4 Chemotherapy · Worsened
103 Participants
205 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 4 Chemotherapy · Stable
91 Participants
148 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 4 Chemotherapy · Improved
76 Participants
181 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 4 Chemotherapy · Worsened
40 Participants
81 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 4 Chemotherapy · Stable
166 Participants
325 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 4 Chemotherapy · Improved
70 Participants
129 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 4 Chemotherapy · Worsened
151 Participants
316 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 4 Chemotherapy · Stable
68 Participants
135 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 4 Chemotherapy · Improved
57 Participants
84 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 4 Chemotherapy · Worsened
68 Participants
153 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 4 Chemotherapy · Stable
135 Participants
255 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 4 Chemotherapy · Improved
73 Participants
127 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 4 Chemotherapy · Worsened
88 Participants
168 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 4 Chemotherapy · Stable
145 Participants
278 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 4 Chemotherapy · Improved
43 Participants
89 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 4 Chemotherapy · Worsened
92 Participants
176 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 4 Chemotherapy · Stable
81 Participants
139 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 4 Chemotherapy · Improved
100 Participants
219 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 6 Chemotherapy · Worsened
99 Participants
216 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 6 Chemotherapy · Stable
97 Participants
168 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 6 Chemotherapy · Improved
70 Participants
148 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 6 Chemotherapy · Worsened
29 Participants
71 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 6 Chemotherapy · Stable
184 Participants
368 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 6 Chemotherapy · Improved
48 Participants
86 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 6 Chemotherapy · Worsened
87 Participants
218 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 6 Chemotherapy · Stable
81 Participants
132 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 6 Chemotherapy · Improved
97 Participants
182 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 6 Chemotherapy · Worsened
32 Participants
66 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 6 Chemotherapy · Stable
148 Participants
312 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 6 Chemotherapy · Improved
87 Participants
156 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 6 Chemotherapy · Worsened
175 Participants
371 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 6 Chemotherapy · Stable
50 Participants
99 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 6 Chemotherapy · Improved
42 Participants
63 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 6 Chemotherapy · Worsened
71 Participants
161 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 6 Chemotherapy · Stable
113 Participants
240 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 6 Chemotherapy · Improved
83 Participants
132 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 6 Chemotherapy · Worsened
77 Participants
173 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 6 Chemotherapy · Stable
144 Participants
279 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 6 Chemotherapy · Improved
46 Participants
80 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 6 Chemotherapy · Worsened
106 Participants
181 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 6 Chemotherapy · Stable
60 Participants
121 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 6 Chemotherapy · Improved
100 Participants
230 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 1 Maintenance · Worsened
95 Participants
187 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 1 Maintenance · Stable
92 Participants
165 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 1 Maintenance · Improved
75 Participants
142 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 1 Maintenance · Worsened
29 Participants
63 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 1 Maintenance · Stable
172 Participants
337 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 1 Maintenance · Improved
53 Participants
85 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 1 Maintenance · Worsened
104 Participants
181 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 1 Maintenance · Stable
73 Participants
143 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 1 Maintenance · Improved
85 Participants
170 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 1 Maintenance · Worsened
25 Participants
55 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 1 Maintenance · Stable
152 Participants
284 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 1 Maintenance · Improved
85 Participants
157 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 1 Maintenance · Worsened
173 Participants
358 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 1 Maintenance · Stable
49 Participants
73 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 1 Maintenance · Improved
40 Participants
64 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 1 Maintenance · Worsened
68 Participants
127 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 1 Maintenance · Stable
115 Participants
239 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 1 Maintenance · Improved
79 Participants
130 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 1 Maintenance · Worsened
66 Participants
162 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 1 Maintenance · Stable
151 Participants
235 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 1 Maintenance · Improved
45 Participants
98 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 1 Maintenance · Worsened
89 Participants
145 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 1 Maintenance · Stable
56 Participants
117 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 1 Maintenance · Improved
115 Participants
232 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 2 Maintenance · Worsened
74 Participants
162 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 2 Maintenance · Stable
85 Participants
143 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 2 Maintenance · Improved
68 Participants
124 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 2 Maintenance · Worsened
16 Participants
53 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 2 Maintenance · Stable
166 Participants
290 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 2 Maintenance · Improved
38 Participants
74 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 2 Maintenance · Worsened
75 Participants
156 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 2 Maintenance · Stable
54 Participants
103 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 2 Maintenance · Improved
98 Participants
169 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 2 Maintenance · Worsened
19 Participants
35 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 2 Maintenance · Stable
127 Participants
260 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 2 Maintenance · Improved
82 Participants
136 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 2 Maintenance · Worsened
128 Participants
277 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 2 Maintenance · Stable
57 Participants
79 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 2 Maintenance · Improved
43 Participants
74 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 2 Maintenance · Worsened
52 Participants
129 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 2 Maintenance · Stable
106 Participants
186 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 2 Maintenance · Improved
70 Participants
115 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 2 Maintenance · Worsened
54 Participants
115 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 2 Maintenance · Stable
125 Participants
229 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 2 Maintenance · Improved
49 Participants
86 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 2 Maintenance · Worsened
48 Participants
85 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 2 Maintenance · Stable
57 Participants
100 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 2 Maintenance · Improved
119 Participants
243 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 3 Maintenance · Worsened
70 Participants
159 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 3 Maintenance · Stable
88 Participants
147 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 3 Maintenance · Improved
74 Participants
135 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 3 Maintenance · Worsened
24 Participants
55 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 3 Maintenance · Stable
161 Participants
291 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 3 Maintenance · Improved
41 Participants
78 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 3 Maintenance · Worsened
71 Participants
161 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 3 Maintenance · Stable
55 Participants
109 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 3 Maintenance · Improved
106 Participants
171 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 3 Maintenance · Worsened
38 Participants
56 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 3 Maintenance · Stable
123 Participants
246 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 3 Maintenance · Improved
72 Participants
140 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 3 Maintenance · Worsened
129 Participants
285 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 3 Maintenance · Stable
53 Participants
91 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 3 Maintenance · Improved
50 Participants
66 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 3 Maintenance · Worsened
69 Participants
144 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 3 Maintenance · Stable
92 Participants
193 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 3 Maintenance · Improved
71 Participants
105 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 3 Maintenance · Worsened
54 Participants
110 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 3 Maintenance · Stable
118 Participants
242 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 3 Maintenance · Improved
60 Participants
90 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 3 Maintenance · Worsened
32 Participants
54 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 3 Maintenance · Stable
66 Participants
96 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 3 Maintenance · Improved
134 Participants
290 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 6 Maintenance · Worsened
54 Participants
126 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 6 Maintenance · Stable
72 Participants
132 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 6 Maintenance · Improved
69 Participants
139 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 6 Maintenance · Worsened
16 Participants
45 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 6 Maintenance · Stable
121 Participants
242 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 6 Maintenance · Improved
53 Participants
95 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 6 Maintenance9 · Worsened
54 Participants
117 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 6 Maintenance9 · Stable
44 Participants
101 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 6 Maintenance9 · Improved
97 Participants
179 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 6 Maintenance · Worsened
22 Participants
49 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 6 Maintenance · Stable
106 Participants
222 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 6 Maintenance · Improved
70 Participants
128 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 6 Maintenance · Worsened
108 Participants
234 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 6 Maintenance · Stable
43 Participants
89 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 6 Maintenance · Improved
47 Participants
75 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 6 Maintenance · Worsened
53 Participants
127 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 6 Maintenance · Stable
85 Participants
164 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 6 Maintenance · Improved
60 Participants
107 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 6 Maintenance · Worsened
37 Participants
102 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 6 Maintenance · Stable
111 Participants
200 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 6 Maintenance · Improved
50 Participants
96 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 6 Maintenance · Worsened
13 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 6 Maintenance · Stable
58 Participants
92 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 6 Maintenance · Improved
125 Participants
282 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 9 Maintenance · Worsened
51 Participants
99 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 9 Maintenance · Stable
59 Participants
130 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 9 Maintenance · Improved
75 Participants
130 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 9 Maintenance · Worsened
19 Participants
40 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 9 Maintenance · Stable
109 Participants
201 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 9 Maintenance · Improved
51 Participants
103 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 9 Maintenance · Worsened
47 Participants
89 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 9 Maintenance · Stable
39 Participants
86 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 9 Maintenance · Improved
99 Participants
184 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 9 Maintenance · Worsened
22 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 9 Maintenance · Stable
103 Participants
198 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 9 Maintenance · Improved
61 Participants
125 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 9 Maintenance · Worsened
91 Participants
206 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 9 Maintenance · Stable
52 Participants
75 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 9 Maintenance · Improved
43 Participants
79 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 9 Maintenance · Worsened
51 Participants
96 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 9 Maintenance · Stable
67 Participants
158 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 9 Maintenance · Improved
68 Participants
106 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 9 Maintenance · Worsened
39 Participants
81 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 9 Maintenance · Stable
101 Participants
193 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 9 Maintenance · Improved
46 Participants
86 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 9 Maintenance · Worsened
7 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 9 Maintenance · Stable
52 Participants
74 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 9 Maintenance · Improved
126 Participants
268 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 12 Maintenance · Worsened
32 Participants
79 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 12 Maintenance · Stable
57 Participants
99 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 12 Maintenance · Improved
67 Participants
130 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 12 Maintenance · Worsened
14 Participants
30 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 12 Maintenance · Stable
86 Participants
178 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 12 Maintenance · Improved
51 Participants
85 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 12 Maintenance · Worsened
35 Participants
83 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 12 Maintenance · Stable
39 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 12 Maintenance · Improved
82 Participants
166 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 12 Maintenance · Worsened
16 Participants
49 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 12 Maintenance · Stable
90 Participants
166 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 12 Maintenance · Improved
52 Participants
93 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 12 Maintenance · Worsened
68 Participants
164 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 12 Maintenance · Stable
46 Participants
73 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 12 Maintenance · Improved
44 Participants
71 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 12 Maintenance · Worsened
44 Participants
91 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 12 Maintenance · Stable
59 Participants
138 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 12 Maintenance · Improved
55 Participants
79 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 12 Maintenance · Worsened
25 Participants
66 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 12 Maintenance · Stable
95 Participants
164 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 12 Maintenance · Improved
38 Participants
78 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 12 Maintenance · Worsened
5 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 12 Maintenance · Stable
44 Participants
68 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 12 Maintenance · Improved
108 Participants
231 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 15 Maintenance · Worsened
40 Participants
73 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 15 Maintenance · Stable
54 Participants
92 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 15 Maintenance · Improved
55 Participants
114 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 15 Maintenance · Worsened
18 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 15 Maintenance · Stable
82 Participants
162 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 15 Maintenance · Improved
44 Participants
68 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 15 Maintenance · Worsened
26 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 15 Maintenance · Stable
35 Participants
69 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 15 Maintenance · Improved
88 Participants
151 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 15 Maintenance · Worsened
22 Participants
30 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 15 Maintenance · Stable
86 Participants
154 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 15 Maintenance · Improved
42 Participants
97 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 15 Maintenance · Worsened
66 Participants
147 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 15 Maintenance · Stable
42 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 15 Maintenance · Improved
42 Participants
72 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 15 Maintenance · Worsened
41 Participants
80 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 15 Maintenance · Stable
62 Participants
116 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 15 Maintenance · Improved
47 Participants
83 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 15 Maintenance · Worsened
30 Participants
60 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 15 Maintenance · Stable
80 Participants
144 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 15 Maintenance · Improved
40 Participants
74 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 15 Maintenance · Worsened
7 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 15 Maintenance · Improved
100 Participants
213 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 17 Maintenance · Worsened
10 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 17 Maintenance · Stable
13 Participants
32 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 17 Maintenance · Improved
16 Participants
35 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 17 Maintenance · Worsened
4 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 17 Maintenance · Improved
16 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 17 Maintenance · Worsened
8 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 17 Maintenance · Stable
6 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 17 Maintenance · Improved
25 Participants
48 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 17 Maintenance · Worsened
7 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 17 Maintenance · Stable
7 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 17 Maintenance · Improved
14 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 17 Maintenance · Worsened
10 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 17 Maintenance · Stable
11 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 17 Maintenance · Improved
19 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 17 Maintenance · Worsened
7 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 17 Maintenance · Stable
20 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 17 Maintenance · Improved
13 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 17 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 17 Maintenance · Stable
10 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 17 Maintenance · Improved
28 Participants
66 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 23 Maintenance · Worsened
9 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 23 Maintenance · Stable
20 Participants
37 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 23 Maintenance · Improved
26 Participants
37 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 23 Maintenance · Worsened
4 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 23 Maintenance · Stable
36 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 23 Maintenance · Improved
14 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 23 Maintenance · Worsened
8 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 23 Maintenance · Stable
15 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, End of treatment · Worsened
42 Participants
97 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 23 Maintenance · Improved
32 Participants
57 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 23 Maintenance · Worsened
8 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 23 Maintenance · Stable
34 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 23 Maintenance · Improved
14 Participants
35 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 23 Maintenance · Worsened
20 Participants
50 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 23 Maintenance · Stable
18 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 23 Maintenance · Improved
18 Participants
32 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 23 Maintenance · Worsened
18 Participants
28 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 23 Maintenance · Stable
25 Participants
46 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 23 Maintenance · Improved
13 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 23 Maintenance · Worsened
9 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 23 Maintenance · Stable
28 Participants
48 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 23 Maintenance · Improved
19 Participants
30 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 23 Maintenance · Worsened
4 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 23 Maintenance · Stable
17 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 23 Maintenance · Improved
35 Participants
74 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 29 Maintenance · Worsened
13 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 29 Maintenance · Stable
18 Participants
29 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 29 Maintenance · Improved
20 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 29 Maintenance · Worsened
5 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 29 Maintenance · Stable
25 Participants
46 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 29 Maintenance · Improved
19 Participants
28 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 29 Maintenance · Worsened
8 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 29 Maintenance · Stable
11 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 29 Maintenance · Improved
32 Participants
55 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 29 Maintenance · Worsened
9 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 29 Maintenance · Stable
30 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 29 Maintenance · Improved
12 Participants
28 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 29 Maintenance · Worsened
17 Participants
48 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 29 Maintenance · Stable
16 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 29 Maintenance · Improved
17 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 29 Maintenance · Worsened
14 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 29 Maintenance · Stable
16 Participants
45 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 29 Maintenance · Improved
20 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 29 Maintenance · Worsened
7 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 29 Maintenance · Improved
13 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 29 Maintenance · Worsened
1 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 29 Maintenance · Stable
14 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 29 Maintenance · Improved
35 Participants
68 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 35 Maintenance · Worsened
13 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 35 Maintenance · Stable
11 Participants
35 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 35 Maintenance · Improved
21 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 35 Maintenance · Worsened
5 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 35 Maintenance · Stable
26 Participants
47 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 35 Maintenance · Improved
13 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 35 Maintenance · Worsened
9 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 35 Maintenance · Stable
11 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 35 Maintenance · Improved
25 Participants
50 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 35 Maintenance · Worsened
6 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 35 Maintenance · Stable
25 Participants
48 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 35 Maintenance · Improved
13 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 35 Maintenance · Worsened
14 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 35 Maintenance · Stable
19 Participants
28 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 35 Maintenance · Improved
12 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 35 Maintenance · Worsened
9 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 35 Maintenance · Stable
17 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 35 Maintenance · Improved
19 Participants
22 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 35 Maintenance · Worsened
10 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 35 Maintenance · Stable
24 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 35 Maintenance · Improved
11 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 35 Maintenance · Worsened
2 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 35 Maintenance · Stable
15 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 35 Maintenance · Improved
28 Participants
64 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 41 Maintenance · Worsened
23 Participants
30 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 41 Maintenance · Stable
15 Participants
36 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 41 Maintenance · Improved
19 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 41 Maintenance · Worsened
6 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 41 Maintenance · Stable
30 Participants
53 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 41 Maintenance · Improved
21 Participants
34 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 41 Maintenance · Worsened
10 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 41 Maintenance · Stable
13 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 41 Maintenance · Improved
34 Participants
57 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 41 Maintenance · Worsened
11 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 41 Maintenance · Stable
31 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 41 Maintenance · Improved
15 Participants
36 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 41 Maintenance · Worsened
25 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 41 Maintenance · Stable
19 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 41 Maintenance · Improved
12 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 41 Maintenance · Worsened
18 Participants
29 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 41 Maintenance · Stable
19 Participants
51 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 41 Maintenance · Improved
19 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 41 Maintenance · Worsened
15 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 41 Maintenance · Stable
26 Participants
50 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 41 Maintenance · Improved
15 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 41 Maintenance · Worsened
3 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 41 Maintenance · Stable
17 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 41 Maintenance · Improved
37 Participants
77 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 47 Maintenance · Worsened
14 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 47 Maintenance · Worsened
6 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 47 Maintenance · Stable
21 Participants
46 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 47 Maintenance · Improved
20 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 47 Maintenance · Worsened
7 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 47 Maintenance · Stable
9 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 47 Maintenance · Improved
31 Participants
47 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 47 Maintenance · Worsened
10 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 47 Maintenance · Stable
28 Participants
44 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 47 Maintenance · Improved
9 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 47 Maintenance · Worsened
21 Participants
40 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 47 Maintenance · Stable
14 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 47 Maintenance · Improved
12 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 47 Maintenance · Worsened
12 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 47 Maintenance · Stable
19 Participants
43 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 47 Maintenance · Improved
16 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 47 Maintenance · Worsened
9 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 47 Maintenance · Stable
29 Participants
44 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 47 Maintenance · Improved
9 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 47 Maintenance · Worsened
5 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 47 Maintenance · Stable
12 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 47 Maintenance · Improved
30 Participants
60 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 53 Maintenance · Worsened
10 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 53 Maintenance · Stable
8 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 53 Maintenance · Improved
8 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 53 Maintenance · Worsened
4 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 53 Maintenance · Stable
11 Participants
32 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 53 Maintenance · Improved
11 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 53 Maintenance · Worsened
3 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 53 Maintenance · Stable
5 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 53 Maintenance · Improved
18 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 53 Maintenance · Worsened
5 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 53 Maintenance · Stable
15 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 53 Maintenance · Improved
6 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 53 Maintenance · Worsened
7 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 53 Maintenance · Stable
13 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 53 Maintenance · Improved
6 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 53 Maintenance · Worsened
7 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 53 Maintenance · Stable
9 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 53 Maintenance · Improved
10 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 53 Maintenance · Worsened
4 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 53 Maintenance · Stable
14 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 53 Maintenance · Improved
8 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 53 Maintenance · Worsened
4 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 53 Maintenance · Stable
8 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 53 Maintenance · Improved
14 Participants
41 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 59 Maintenance · Worsened
6 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 59 Maintenance · Stable
6 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 59 Maintenance · Improved
6 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 59 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 59 Maintenance · Stable
9 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 59 Maintenance · Improved
8 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 59 Maintenance · Worsened
3 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 59 Maintenance · Stable
5 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 59 Maintenance · Improved
10 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 59 Maintenance · Worsened
3 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 59 Maintenance · Stable
12 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 59 Maintenance · Improved
3 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 59 Maintenance · Worsened
7 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 59 Maintenance · Stable
6 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 59 Maintenance · Improved
5 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 59 Maintenance · Worsened
5 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 59 Maintenance · Stable
6 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 59 Maintenance · Improved
7 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 59 Maintenance · Worsened
3 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 59 Maintenance · Stable
10 Participants
22 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 59 Maintenance · Improved
5 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 59 Maintenance · Worsened
4 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 59 Maintenance · Stable
4 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 59 Maintenance · Improved
10 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 65 Maintenance · Worsened
3 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 65 Maintenance · Stable
4 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 65 Maintenance · Improved
5 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 65 Maintenance · Worsened
2 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 65 Maintenance · Stable
5 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 65 Maintenance · Improved
5 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 65 Maintenance · Worsened
1 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 65 Maintenance · Stable
5 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 65 Maintenance · Improved
6 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 65 Maintenance · Worsened
2 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 65 Maintenance · Stable
9 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 65 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 65 Maintenance · Worsened
5 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 65 Maintenance · Stable
5 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 65 Maintenance · Improved
2 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 65 Maintenance · Worsened
3 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 65 Maintenance · Stable
3 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 65 Maintenance · Improved
6 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 65 Maintenance · Worsened
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 65 Maintenance · Stable
9 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 65 Maintenance · Improved
1 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 65 Maintenance · Worsened
4 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 65 Maintenance · Stable
4 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 65 Maintenance · Improved
4 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 71 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 71 Maintenance · Stable
1 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 71 Maintenance · Improved
6 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 71 Maintenance · Worsened
2 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 71 Maintenance · Stable
4 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 71 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 71 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 71 Maintenance · Stable
1 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 71 Maintenance · Improved
6 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 71 Maintenance · Worsened
3 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 71 Maintenance · Stable
4 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 71 Maintenance · Improved
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 71 Maintenance · Worsened
2 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 71 Maintenance · Stable
4 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 71 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 71 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 71 Maintenance · Stable
1 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 71 Maintenance · Improved
5 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 71 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 71 Maintenance · Stable
5 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 71 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 71 Maintenance · Worsened
3 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 71 Maintenance · Stable
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 71 Maintenance · Improved
3 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 77 Maintenance · Worsened
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 77 Maintenance · Stable
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 77 Maintenance · Improved
2 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 77 Maintenance · Worsened
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 77 Maintenance · Stable
2 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 77 Maintenance · Improved
0 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 77 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 77 Maintenance · Stable
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 77 Maintenance · Improved
3 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 77 Maintenance · Worsened
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 77 Maintenance · Stable
2 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 77 Maintenance · Improved
2 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 77 Maintenance · Worsened
2 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 77 Maintenance · Stable
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 77 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 77 Maintenance · Worsened
0 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 77 Maintenance · Stable
0 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 77 Maintenance · Improved
4 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 77 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 77 Maintenance · Stable
2 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 77 Maintenance · Improved
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 77 Maintenance · Worsened
0 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 77 Maintenance · Stable
2 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 77 Maintenance · Improved
2 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 83 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 83 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 83 Maintenance · Improved
2 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 83 Maintenance · Worsened
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 83 Maintenance · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 83 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 83 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 83 Maintenance · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 83 Maintenance · Improved
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 83 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 83 Maintenance · Stable
2 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 83 Maintenance · Improved
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 83 Maintenance · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 83 Maintenance · Improved
2 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 83 Maintenance · Stable
0 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 83 Maintenance · Improved
3 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 83 Maintenance · Worsened
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 83 Maintenance · Stable
1 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 83 Maintenance · Improved
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 83 Maintenance · Worsened
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 83 Maintenance · Stable
2 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 83 Maintenance · Improved
1 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 89 Maintenance · Stable
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Cycle 89 Maintenance · Improved
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 89 Maintenance · Stable
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Cycle 89 Maintenance · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 89 Maintenance · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 89 Maintenance · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Cycle 89 Maintenance · Improved
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, End of treatment · Worsened
45 Participants
94 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, End of treatment · Stable
68 Participants
109 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, End of treatment · Improved
68 Participants
134 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, End of treatment · Worsened
21 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, End of treatment · Stable
122 Participants
206 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, End of treatment · Improved
33 Participants
66 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, End of treatment · Worsened
65 Participants
124 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, End of treatment · Stable
43 Participants
72 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, End of treatment · Improved
72 Participants
142 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, End of treatment · Worsened
45 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, End of treatment · Stable
90 Participants
186 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, End of treatment · Improved
46 Participants
96 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, End of treatment · Worsened
79 Participants
171 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, End of treatment · Stable
52 Participants
83 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, End of treatment · Improved
50 Participants
85 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 63 months) · Worsened
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, End of treatment · Stable
83 Participants
149 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, End of treatment · Improved
56 Participants
94 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, End of treatment · Worsened
35 Participants
75 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, End of treatment · Stable
94 Participants
180 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, End of treatment · Improved
52 Participants
85 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, End of treatment · Worsened
13 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, End of treatment · Stable
45 Participants
76 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, End of treatment · Improved
122 Participants
240 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Safety Follow-up · Worsened
42 Participants
94 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Safety Follow-up · Stable
47 Participants
84 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, Safety Follow-up · Improved
52 Participants
102 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Safety Follow-up · Worsened
16 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Safety Follow-up · Stable
90 Participants
175 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 63 months) · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, Safety Follow-up · Improved
28 Participants
55 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Safety Follow-up · Worsened
50 Participants
111 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Safety Follow-up · Stable
32 Participants
67 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, Safety Follow-up · Improved
59 Participants
103 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Safety Follow-up · Worsened
22 Participants
55 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Safety Follow-up · Stable
78 Participants
152 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, Safety Follow-up · Improved
43 Participants
75 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Safety Follow-up · Worsened
72 Participants
151 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Safety Follow-up · Stable
36 Participants
70 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, Safety Follow-up · Improved
35 Participants
61 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Safety Follow-up · Worsened
29 Participants
83 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Safety Follow-up · Stable
67 Participants
130 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, Safety Follow-up · Improved
47 Participants
69 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Safety Follow-up · Worsened
29 Participants
66 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Safety Follow-up · Stable
77 Participants
139 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, Safety Follow-up · Improved
37 Participants
77 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Safety Follow-up · Worsened
15 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Safety Follow-up · Stable
37 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, Safety Follow-up · Improved
90 Participants
203 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 3 months) · Worsened
47 Participants
79 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 3 months) · Stable
46 Participants
83 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 3 months) · Improved
41 Participants
81 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 3 months) · Worsened
24 Participants
35 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 3 months) · Stable
79 Participants
157 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 3 months) · Improved
25 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 3 months) · Worsened
46 Participants
88 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 3 months) · Stable
33 Participants
47 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 3 months) · Improved
55 Participants
108 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 3 months) · Worsened
23 Participants
44 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 3 months) · Stable
68 Participants
132 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 3 months) · Improved
43 Participants
67 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 3 months) · Worsened
63 Participants
135 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 3 months) · Stable
39 Participants
56 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 3 months) · Improved
32 Participants
52 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 3 months) · Worsened
27 Participants
56 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 3 months) · Stable
52 Participants
108 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 3 months) · Improved
55 Participants
78 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 3 months) · Worsened
30 Participants
67 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 3 months) · Stable
79 Participants
116 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 3 months) · Improved
25 Participants
60 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 3 months) · Worsened
17 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 3 months) · Stable
29 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 3 months) · Improved
86 Participants
173 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 9 months) · Worsened
36 Participants
56 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 9 months) · Stable
37 Participants
56 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 9 months) · Improved
34 Participants
68 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 9 months) · Worsened
13 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 9 months) · Stable
74 Participants
110 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 9 months) · Improved
19 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 9 months) · Worsened
42 Participants
67 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 9 months) · Stable
17 Participants
28 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 9 months) · Improved
47 Participants
84 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 9 months) · Worsened
18 Participants
35 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 9 months) · Stable
58 Participants
86 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 9 months) · Improved
31 Participants
59 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 9 months) · Worsened
60 Participants
92 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 9 months) · Stable
24 Participants
47 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 9 months) · Improved
23 Participants
41 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 9 months) · Worsened
22 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 9 months) · Stable
50 Participants
82 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 9 months) · Improved
35 Participants
60 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 9 months) · Worsened
32 Participants
48 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 9 months) · Stable
54 Participants
88 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 9 months) · Improved
21 Participants
44 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 9 months) · Worsened
12 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 9 months) · Stable
26 Participants
40 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 9 months) · Improved
69 Participants
123 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 15 months) · Worsened
22 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 15 months) · Stable
31 Participants
46 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 15 months) · Improved
23 Participants
61 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 15 months) · Worsened
12 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 15 months) · Stable
43 Participants
86 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 15 months) · Improved
15 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 15 months) · Worsened
30 Participants
54 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 15 months) · Stable
16 Participants
33 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 15 months) · Improved
30 Participants
61 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 15 months) · Worsened
19 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 15 months) · Stable
37 Participants
81 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 15 months) · Improved
20 Participants
45 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 15 months) · Worsened
43 Participants
79 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 15 months) · Stable
13 Participants
40 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 15 months) · Improved
20 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 15 months) · Worsened
17 Participants
37 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 15 months) · Stable
41 Participants
78 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 15 months) · Improved
18 Participants
34 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 15 months) · Worsened
19 Participants
45 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 15 months) · Stable
41 Participants
73 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 15 months) · Improved
16 Participants
29 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 15 months) · Worsened
7 Participants
13 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 15 months) · Stable
21 Participants
34 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 15 months) · Improved
48 Participants
101 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 21 months) · Worsened
12 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 21 months) · Stable
18 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 21 months) · Improved
16 Participants
39 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 21 months) · Worsened
5 Participants
13 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 21 months) · Stable
26 Participants
62 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 21 months) · Improved
13 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 21 months) · Worsened
17 Participants
36 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 21 months) · Stable
11 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 21 months) · Improved
18 Participants
42 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 21 months) · Worsened
12 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 21 months) · Stable
25 Participants
48 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 21 months) · Improved
10 Participants
29 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 21 months) · Worsened
18 Participants
53 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 21 months) · Stable
13 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 21 months) · Improved
15 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 21 months) · Worsened
12 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 21 months) · Stable
21 Participants
44 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 21 months) · Improved
14 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 21 months) · Worsened
10 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 21 months) · Stable
27 Participants
50 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 21 months) · Improved
9 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 21 months) · Worsened
4 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 21 months) · Stable
6 Participants
22 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 21 months) · Improved
37 Participants
62 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 27 months) · Worsened
10 Participants
21 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 27 months) · Stable
15 Participants
22 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 63 months) · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 63 months) · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 63 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 63 months) · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 63 months) · Improved
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 63 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 63 months) · Stable
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 63 months) · Improved
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 27 months) · Improved
10 Participants
26 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 27 months) · Worsened
6 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 27 months) · Stable
18 Participants
41 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 27 months) · Improved
8 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 27 months) · Worsened
16 Participants
28 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 27 months) · Stable
7 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 27 months) · Improved
11 Participants
27 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 27 months) · Worsened
5 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 27 months) · Stable
21 Participants
38 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 27 months) · Improved
9 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 27 months) · Worsened
19 Participants
36 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 27 months) · Stable
9 Participants
16 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 27 months) · Improved
7 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 27 months) · Worsened
8 Participants
17 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 27 months) · Stable
18 Participants
29 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 27 months) · Improved
9 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 27 months) · Worsened
11 Participants
24 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 27 months) · Stable
18 Participants
31 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 27 months) · Improved
6 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 27 months) · Worsened
6 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 27 months) · Stable
7 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 27 months) · Improved
22 Participants
47 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 33 months) · Worsened
1 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 33 months) · Stable
8 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 33 months) · Improved
7 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 33 months) · Worsened
0 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 33 months) · Stable
13 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 33 months) · Improved
3 Participants
9 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 33 months) · Worsened
9 Participants
15 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 33 months) · Stable
4 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 33 months) · Improved
3 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 33 months) · Worsened
4 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 33 months) · Stable
7 Participants
25 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 33 months) · Improved
5 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 33 months) · Worsened
8 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 33 months) · Stable
5 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 33 months) · Improved
2 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 33 months) · Worsened
2 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 33 months) · Worsened
4 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 33 months) · Stable
7 Participants
20 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 33 months) · Improved
4 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 33 months) · Worsened
1 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 33 months) · Stable
3 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 33 months) · Improved
11 Participants
23 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 39 months) · Worsened
3 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 39 months) · Stable
6 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 39 months) · Improved
2 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 39 months) · Worsened
0 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 39 months) · Stable
10 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 39 months) · Improved
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 39 months) · Worsened
3 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 39 months) · Stable
3 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 39 months) · Improved
5 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 39 months) · Worsened
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 39 months) · Stable
6 Participants
18 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 39 months) · Improved
3 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 39 months) · Worsened
5 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 39 months) · Stable
4 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 39 months) · Improved
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 39 months) · Worsened
4 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 39 months) · Stable
6 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 39 months) · Improved
1 Participants
7 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 39 months) · Worsened
3 Participants
8 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 39 months) · Stable
7 Participants
14 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 39 months) · Improved
1 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 39 months) · Worsened
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 39 months) · Stable
3 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 39 months) · Improved
7 Participants
19 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 45 months) · Worsened
1 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 45 months) · Stable
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 45 months) · Improved
1 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 45 months) · Worsened
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 45 months) · Stable
3 Participants
11 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 45 months) · Improved
0 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 45 months) · Worsened
3 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 45 months) · Stable
0 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 45 months) · Improved
1 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 45 months) · Worsened
0 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 45 months) · Stable
2 Participants
10 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 45 months) · Improved
2 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 45 months) · Stable
0 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 45 months) · Improved
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 45 months) · Worsened
0 Participants
6 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 45 months) · Stable
3 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 45 months) · Improved
1 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 45 months) · Worsened
1 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 45 months) · Improved
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 45 months) · Worsened
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 45 months) · Stable
3 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 45 months) · Improved
1 Participants
12 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 51 months) · Worsened
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 51 months) · Stable
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 51 months) · Improved
0 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 51 months) · Worsened
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 51 months) · Stable
0 Participants
4 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 51 months) · Improved
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 51 months) · Worsened
2 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 51 months) · Stable
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
ATD, LTFU (EOT + 51 months) · Improved
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 51 months) · Stable
2 Participants
5 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
AS, LTFU (EOT + 51 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 51 months) · Worsened
2 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 51 months) · Stable
0 Participants
2 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
PN, LTFU (EOT + 51 months) · Improved
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 51 months) · Improved
1 Participants
3 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 57 months) · Stable
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
BI, LTFU (EOT + 57 months) · Improved
1 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 57 months) · Worsened
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 57 months) · Stable
0 Participants
1 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
S, LTFU (EOT + 57 months) · Improved
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
MS, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
CSE, LTFU (EOT + 57 months) · Worsened
1 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 57 months) · Worsened
0 Participants
0 Participants
Number of Participants With Change in Status in EORTC-QLQ Ovarian Cancer Module (EORTC-QLQ-OV28) Questionnaire
HS, LTFU (EOT + 57 months) · Stable
0 Participants
1 Participants

Adverse Events

Not Treated

Serious events: 35 serious events
Other events: 51 other events
Deaths: 33 deaths

Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1)

Serious events: 63 serious events
Other events: 158 other events
Deaths: 106 deaths

Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)

Serious events: 190 serious events
Other events: 417 other events
Deaths: 235 deaths

Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)

Serious events: 405 serious events
Other events: 745 other events
Deaths: 430 deaths

Serious adverse events

Serious adverse events
Measure
Not Treated
n=79 participants at risk
Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter\^2(m\^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period. They were not randomized to chemotherapy treatment period and no study intervention was administered.
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1)
n=159 participants at risk
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo (Pbo) on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles starting with Cycle 2, with optional Bevacizumab (Bev) as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib placebo Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision.
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=417 participants at risk
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision.
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=745 participants at risk
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision.
Gastrointestinal disorders
Abdominal pain
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.8%
6/159 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.4%
10/417 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.4%
25/745 • Number of events 28 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Small intestinal obstruction
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.5%
4/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.9%
12/417 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.8%
21/745 • Number of events 25 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Intestinal obstruction
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
3/159 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.6%
11/417 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.3%
17/745 • Number of events 20 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Vomiting
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
9/745 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Diarrhoea
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
5/417 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.1%
8/745 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Colitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.1%
8/745 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Constipation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Nausea
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.67%
5/745 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Ileus
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Subileus
2.5%
2/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Large intestine perforation
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Pancreatitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Ascites
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Enterocolitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Intestinal perforation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal distension
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Anal fistula
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Colonic fistula
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Diarrhoea haemorrhagic
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastrointestinal toxicity
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Haematemesis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Intestinal ischaemia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Small intestinal perforation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Stomatitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Diaphragmatic hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Duodenal obstruction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Enteritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastric haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastric ulcer haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastrointestinal fistula
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastrointestinal obstruction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Hernial eventration
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Ileus paralytic
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Immune-mediated enterocolitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Immune-mediated gastritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Impaired gastric emptying
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Incarcerated inguinal hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Incarcerated umbilical hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Intestinal prolapse
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Intra-abdominal haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Irritable bowel syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Melaena
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Neutropenic colitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Oesophagitis ulcerative
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Proctalgia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Rectal perforation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Retroperitoneal haematoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Umbilical hernia, obstructive
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Vasculitis gastrointestinal
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Volvulus
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Volvulus of small bowel
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
COVID-19
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.7%
7/417 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.5%
11/745 • Number of events 14 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Sepsis
2.5%
2/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.5%
11/745 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Urinary tract infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
3/159 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.6%
12/745 • Number of events 15 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pneumonia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.4%
6/417 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
9/745 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Abdominal abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.67%
5/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pyelonephritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Septic shock
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Device related infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Neutropenic sepsis
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Urosepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Vascular device infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
COVID-19 pneumonia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Clostridium difficile infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Device related sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Enterocolitis infectious
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Escherichia sepsis
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pelvic abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Peritonitis
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pneumocystis jirovecii pneumonia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Suspected COVID-19
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Wound infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Abdominal infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Cellulitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Clostridial sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Clostridium difficile colitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Device related bacteraemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Enterobacter sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Klebsiella sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Post procedural infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Splenic abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Staphylococcal infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Appendiceal abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Appendicitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Appendicitis perforated
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Arthritis bacterial
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Atypical pneumonia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Bacteraemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Bacterial sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Bronchitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Clostridial infection
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Coronavirus infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Diverticulitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Diverticulitis intestinal perforated
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Encephalitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Endocarditis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Escherichia infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Gastroenteritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Gastroenteritis shigella
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Gastrointestinal infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Haemophilus infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Hepatitis A
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Herpes zoster
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Infected lymphocele
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Infected seroma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Large intestine infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Legionella infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Listeria sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Meningitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Meningoencephalitis viral
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Nasal abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Neutropenic infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Perirectal abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pharyngitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Post procedural cellulitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Post procedural sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pseudomonas infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Pulmonary sepsis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Respiratory syncytial virus infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Skin infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Soft tissue infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Stoma site infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Streptococcal infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Subdiaphragmatic abscess
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Tooth infection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Urinary tract infection pseudomonal
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Vulvitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Wound infection staphylococcal
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.0%
25/417 • Number of events 27 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.2%
31/745 • Number of events 35 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Anaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
3/159 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.6%
19/417 • Number of events 24 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.8%
28/745 • Number of events 30 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Febrile neutropenia
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.4%
6/417 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.7%
20/745 • Number of events 20 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Neutropenia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
3/159 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
8/417 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.94%
7/745 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Pancytopenia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.4%
6/417 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Febrile bone marrow aplasia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Leukopenia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Aplasia pure red cell
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Acquired amegakaryocytic thrombocytopenia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Atypical haemolytic uraemic syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Cytopenia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Haematotoxicity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Haemolytic anaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Splenic haematoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Thrombotic microangiopathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
3/159 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.7%
7/417 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.7%
13/745 • Number of events 14 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
2/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.7%
7/417 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
10/745 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.3%
10/745 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.1%
8/745 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Hypoxia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pulmonary amyloidosis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Pyrexia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.5%
4/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.8%
21/745 • Number of events 23 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Asthenia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.94%
7/745 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
General physical health deterioration
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Mucosal inflammation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Chest pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Fatigue
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Hyperthermia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Inflammation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Malaise
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Chest discomfort
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Hernia obstructive
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Impaired healing
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Multiple organ dysfunction syndrome
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Non-cardiac chest pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Oedema peripheral
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Performance status decreased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Sudden cardiac death
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Sudden death
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Platelet count decreased
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.4%
10/417 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.8%
28/745 • Number of events 30 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Alanine aminotransferase increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.1%
8/745 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Neutrophil count decreased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.67%
5/745 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Aspartate aminotransferase increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Blood creatinine increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
SARS-CoV-2 test positive
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Transaminases increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Blood alkaline phosphatase increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
White blood cell count decreased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
General physical condition abnormal
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Haemoglobin decreased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Hepatic enzyme abnormal
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Hepatic enzyme increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Dehydration
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.4%
6/417 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
9/745 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
5/417 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hyperglycaemia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Failure to thrive
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Malnutrition
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Acidosis
1.3%
1/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Calciphylaxis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Ketoacidosis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Type 1 diabetes mellitus
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Postoperative ileus
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Wound dehiscence
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Abdominal wound dehiscence
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Fall
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Failure to anastomose
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Eye disorders
Uveitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Iatrogenic injury
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Incarcerated incisional hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Incisional hernia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Joint dislocation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Postoperative respiratory failure
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Procedural complication
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Procedural haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Procedural intestinal perforation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Toxicity to various agents
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Vulvovaginal injury
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Cerebrovascular accident
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Syncope
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Transient ischaemic attack
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.67%
5/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Loss of consciousness
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Dizziness
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Encephalopathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Headache
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Neuropathy peripheral
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Sciatica
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Aphasia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Cognitive disorder
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Epilepsy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Facial paralysis
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Myasthenic syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Neuralgia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Optic neuritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Parkinsonism
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Posterior reversible encephalopathy syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Transient aphasia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
VIth nerve paralysis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Embolism
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Hypertension
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.81%
6/745 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Deep vein thrombosis
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Hypotension
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Lymphocele
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Circulatory collapse
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Hypertensive urgency
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Jugular vein thrombosis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Orthostatic hypotension
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Peripheral ischaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Vasculitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Atrial fibrillation
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Myocardial infarction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Supraventricular tachycardia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Acute coronary syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Cardiac arrest
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Cardiomyopathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Myocarditis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Sinus tachycardia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Acute cardiac event
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Acute left ventricular failure
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Acute myocardial infarction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Angina unstable
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Atrial thrombosis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Cardiac failure
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Cardiac failure acute
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Cardiac failure congestive
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Coronary artery disease
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Immune-mediated myocarditis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Myocardial ischaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Palpitations
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Pericarditis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Stress cardiomyopathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Ventricular extrasystoles
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Acute kidney injury
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
9/745 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Renal failure
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Urinary retention
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Hydronephrosis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Pyelocaliectasis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Tubulointerstitial nephritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Immune-mediated nephritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Nephritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Obstructive nephropathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Renal colic
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Urinary bladder polyp
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Urogenital fistula
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Vesical fistula
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.54%
4/745 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute monocytic leukaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Sertoli-Leydig cell tumour
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Cholecystitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.40%
3/745 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Autoimmune hepatitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Cholangitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Hepatitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Bile duct stone
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Adrenal insufficiency
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.67%
5/745 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Hypophysitis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Autoimmune thyroiditis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Hypothyroidism
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Immune-mediated hypothyroidism
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Primary hypothyroidism
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Secondary adrenocortical insufficiency
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Degenerative bone disease
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Depression
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.48%
2/417 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Delirium
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Mental status changes
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Suicide attempt
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Anxiety
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Confusional state
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Suicidal ideation
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Drug hypersensitivity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Hypersensitivity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Anaphylactic reaction
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Cytokine release syndrome
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.24%
1/417 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Sarcoidosis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Rash
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Reproductive system and breast disorders
Pelvic pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.72%
3/417 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Reproductive system and breast disorders
Pelvic fluid collection
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Reproductive system and breast disorders
Pelvic haematoma
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Reproductive system and breast disorders
Vaginal discharge
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.63%
1/159 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/745 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Eye disorders
Retinal detachment
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.27%
2/745 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Eye disorders
Blindness
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Eye disorders
Vitreous floaters
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Ear and labyrinth disorders
Deafness
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Product Issues
Device breakage
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Surgical and medical procedures
Ileostomy closure
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/417 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.13%
1/745 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).

Other adverse events

Other adverse events
Measure
Not Treated
n=79 participants at risk
Eligible participants with ovarian cancer received standard of care (SOC) chemotherapy as combination of 175 milligram (mg)/meter\^2(m\^2) Paclitaxel, area under the curve (AUC) of 5 to 6 mg/millilitre (mL)/minute Carboplatin and optional 7.5 mg/kilogram (kg) or 15 mg/kg Bevacizumab as intravenous (IV) infusion on Day 1 of Cycle 1 in Chemotherapy Run-In Period. They were not randomized to chemotherapy treatment period and no study intervention was administered.
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib Pbo+Dostarlimab Pbo +/-Bev (Arm1)
n=159 participants at risk
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo (Pbo) on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles starting with Cycle 2, with optional Bevacizumab (Bev) as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib placebo Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision.
Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)
n=417 participants at risk
Participants received intravenous (IV) infusion of Carboplatin+Paclitaxel along with Dostarlimab placebo on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab Placebo on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision.
Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)
n=745 participants at risk
Participants received intravenous (IV) infusion of Carboplatin + Paclitaxel along with Dostarlimab on Day 1 of each 21-day (Q21D) cycle for up to 5 cycles, starting with Cycle 2 with optional Bevacizumab as part of Chemotherapy. Following this, as part of Maintenance, participants received IV infusion of 1000 mg Dostarlimab on Day 1 every 6 weeks in combination with/without 7.5 mg/kg or 15 mg/kg Bevacizumab Q21D along with oral niraparib Q21D until disease progression, unacceptable toxicity, participant withdrawal, or Investigator decision.
Gastrointestinal disorders
Nausea
19.0%
15/79 • Number of events 16 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
54.1%
86/159 • Number of events 150 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
60.2%
251/417 • Number of events 485 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
59.5%
443/745 • Number of events 1010 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Constipation
8.9%
7/79 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
44.0%
70/159 • Number of events 106 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
46.3%
193/417 • Number of events 339 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
49.0%
365/745 • Number of events 617 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Diarrhoea
13.9%
11/79 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
39.6%
63/159 • Number of events 94 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
35.5%
148/417 • Number of events 282 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
39.7%
296/745 • Number of events 560 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal pain
10.1%
8/79 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
29.6%
47/159 • Number of events 64 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
28.5%
119/417 • Number of events 184 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
35.2%
262/745 • Number of events 410 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Vomiting
13.9%
11/79 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
21.4%
34/159 • Number of events 52 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
31.7%
132/417 • Number of events 197 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
32.2%
240/745 • Number of events 419 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Stomatitis
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.5%
12/159 • Number of events 15 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.5%
48/417 • Number of events 66 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.8%
103/745 • Number of events 167 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal pain upper
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
8/159 • Number of events 14 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.8%
45/417 • Number of events 57 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.6%
79/745 • Number of events 90 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal distension
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.9%
11/159 • Number of events 16 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.9%
33/417 • Number of events 39 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.2%
76/745 • Number of events 97 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Dyspepsia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.5%
12/159 • Number of events 16 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.9%
37/417 • Number of events 44 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.1%
60/745 • Number of events 74 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Dry mouth
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.1%
5/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
21/417 • Number of events 27 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.5%
71/745 • Number of events 86 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Gastrooesophageal reflux disease
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.4%
15/159 • Number of events 16 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.8%
24/417 • Number of events 30 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.8%
51/745 • Number of events 54 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
10/159 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
21/417 • Number of events 29 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.9%
29/745 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.4%
7/159 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
21/417 • Number of events 25 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.4%
25/745 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Fatigue
7.6%
6/79 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
38.4%
61/159 • Number of events 98 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
36.2%
151/417 • Number of events 306 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
46.4%
346/745 • Number of events 673 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Asthenia
10.1%
8/79 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
33.3%
53/159 • Number of events 126 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
37.9%
158/417 • Number of events 365 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
34.1%
254/745 • Number of events 671 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Pyrexia
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.9%
11/159 • Number of events 16 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.6%
40/417 • Number of events 51 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.0%
119/745 • Number of events 152 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Oedema peripheral
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.9%
11/159 • Number of events 17 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.6%
40/417 • Number of events 48 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.2%
76/745 • Number of events 95 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Mucosal inflammation
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.9%
11/159 • Number of events 14 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.9%
37/417 • Number of events 47 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.4%
70/745 • Number of events 104 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
General disorders
Pain
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
10/159 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.7%
28/417 • Number of events 33 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.8%
51/745 • Number of events 67 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Anaemia
13.9%
11/79 • Number of events 18 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
44.0%
70/159 • Number of events 167 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
64.5%
269/417 • Number of events 914 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
65.1%
485/745 • Number of events 1755 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Neutropenia
6.3%
5/79 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
31.4%
50/159 • Number of events 115 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
37.4%
156/417 • Number of events 442 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
34.9%
260/745 • Number of events 764 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Thrombocytopenia
3.8%
3/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.8%
22/159 • Number of events 40 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
39.3%
164/417 • Number of events 477 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
35.3%
263/745 • Number of events 796 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Blood and lymphatic system disorders
Leukopenia
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
8/159 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.0%
29/417 • Number of events 98 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.5%
63/745 • Number of events 157 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Neuropathy peripheral
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
47.8%
76/159 • Number of events 128 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
41.5%
173/417 • Number of events 322 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
41.9%
312/745 • Number of events 551 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Headache
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
26.4%
42/159 • Number of events 57 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
25.4%
106/417 • Number of events 182 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
26.7%
199/745 • Number of events 307 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Dizziness
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.1%
16/159 • Number of events 21 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
15.1%
63/417 • Number of events 93 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.8%
125/745 • Number of events 176 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
15.7%
25/159 • Number of events 45 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
14.1%
59/417 • Number of events 95 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
15.8%
118/745 • Number of events 193 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Dysgeusia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.1%
16/159 • Number of events 18 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.2%
34/417 • Number of events 43 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.4%
85/745 • Number of events 104 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Paraesthesia
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 15 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.6%
40/417 • Number of events 53 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.4%
55/745 • Number of events 74 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Nervous system disorders
Neurotoxicity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.1%
13/417 • Number of events 28 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.4%
25/745 • Number of events 46 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Alopecia
5.1%
4/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
41.5%
66/159 • Number of events 79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
46.3%
193/417 • Number of events 258 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
44.0%
328/745 • Number of events 411 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Rash
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
12.6%
20/159 • Number of events 30 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.5%
48/417 • Number of events 62 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
21.2%
158/745 • Number of events 313 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.5%
12/159 • Number of events 14 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.6%
44/417 • Number of events 72 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
18.5%
138/745 • Number of events 200 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Dry skin
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.5%
4/159 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.2%
30/417 • Number of events 33 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.1%
53/745 • Number of events 57 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.1%
17/417 • Number of events 18 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.7%
57/745 • Number of events 84 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Platelet count decreased
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
15.7%
25/159 • Number of events 57 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
27.3%
114/417 • Number of events 349 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
30.7%
229/745 • Number of events 695 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Neutrophil count decreased
3.8%
3/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
18.2%
29/159 • Number of events 56 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
19.7%
82/417 • Number of events 228 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
24.3%
181/745 • Number of events 499 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Alanine aminotransferase increased
3.8%
3/79 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.5%
12/159 • Number of events 23 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.0%
46/417 • Number of events 102 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.4%
122/745 • Number of events 257 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Weight decreased
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.2%
21/159 • Number of events 29 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.8%
49/417 • Number of events 68 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
14.8%
110/745 • Number of events 178 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Aspartate aminotransferase increased
2.5%
2/79 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
10/159 • Number of events 17 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.8%
49/417 • Number of events 87 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
15.7%
117/745 • Number of events 254 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
White blood cell count decreased
7.6%
6/79 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.5%
12/159 • Number of events 25 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.9%
37/417 • Number of events 69 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
12.6%
94/745 • Number of events 284 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Blood creatinine increased
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.5%
4/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.1%
38/417 • Number of events 76 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.0%
97/745 • Number of events 216 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Amylase increased
1.3%
1/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.4%
7/159 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.8%
20/417 • Number of events 33 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.1%
60/745 • Number of events 117 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Blood alkaline phosphatase increased
1.3%
1/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.9%
3/159 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.4%
10/417 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.9%
59/745 • Number of events 137 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.6%
19/417 • Number of events 24 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.8%
36/745 • Number of events 48 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Arthralgia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
40.3%
64/159 • Number of events 132 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
37.2%
155/417 • Number of events 291 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
39.3%
293/745 • Number of events 527 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Myalgia
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
18.9%
30/159 • Number of events 39 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
21.1%
88/417 • Number of events 151 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
21.9%
163/745 • Number of events 252 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.4%
26/159 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
14.1%
59/417 • Number of events 81 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.5%
123/745 • Number of events 163 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.9%
19/159 • Number of events 24 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.3%
47/417 • Number of events 71 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.0%
82/745 • Number of events 96 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.4%
7/159 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.9%
33/417 • Number of events 44 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
47/745 • Number of events 64 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Muscular weakness
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.4%
7/159 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.0%
25/417 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.7%
50/745 • Number of events 69 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Muscle spasms
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
10/159 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.2%
26/417 • Number of events 32 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.8%
43/745 • Number of events 52 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.4%
7/159 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.3%
22/417 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.8%
28/745 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Decreased appetite
10.1%
8/79 • Number of events 8 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
19.5%
31/159 • Number of events 40 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
24.0%
100/417 • Number of events 140 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
31.3%
233/745 • Number of events 388 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypomagnesaemia
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
18.9%
30/159 • Number of events 46 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
21.8%
91/417 • Number of events 180 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
23.1%
172/745 • Number of events 313 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypokalaemia
7.6%
6/79 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.1%
16/159 • Number of events 27 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.3%
47/417 • Number of events 73 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
14.6%
109/745 • Number of events 247 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hyponatraemia
5.1%
4/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
10/159 • Number of events 24 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.8%
20/417 • Number of events 49 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.2%
61/745 • Number of events 144 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hyperglycaemia
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 15 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.7%
32/417 • Number of events 49 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.8%
51/745 • Number of events 95 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Dehydration
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 11 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.8%
24/417 • Number of events 26 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.4%
40/745 • Number of events 49 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hypoalbuminaemia
8.9%
7/79 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.4%
7/159 • Number of events 14 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.6%
11/417 • Number of events 16 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.2%
39/745 • Number of events 104 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Metabolism and nutrition disorders
Hyperkalaemia
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.9%
12/417 • Number of events 21 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.6%
19/745 • Number of events 28 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
Urinary tract infection
5.1%
4/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
17.0%
27/159 • Number of events 54 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
19.9%
83/417 • Number of events 140 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
19.2%
143/745 • Number of events 234 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Infections and infestations
COVID-19
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.1%
5/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
12.0%
50/417 • Number of events 55 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
12.9%
96/745 • Number of events 108 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
3.8%
3/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
12.6%
20/159 • Number of events 24 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
20.9%
87/417 • Number of events 127 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
24.6%
183/745 • Number of events 275 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Cough
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.2%
21/159 • Number of events 26 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.9%
58/417 • Number of events 64 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.2%
121/745 • Number of events 164 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
13.2%
21/159 • Number of events 26 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
14.4%
60/417 • Number of events 79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
16.1%
120/745 • Number of events 166 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.1%
5/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
4.8%
20/417 • Number of events 20 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.5%
41/745 • Number of events 45 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Hypertension
3.8%
3/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
25.8%
41/159 • Number of events 81 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
30.2%
126/417 • Number of events 262 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
31.7%
236/745 • Number of events 509 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Vascular disorders
Hot flush
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.7%
17/159 • Number of events 22 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.0%
46/417 • Number of events 59 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.3%
69/745 • Number of events 78 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Insomnia
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
15.7%
25/159 • Number of events 31 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
20.1%
84/417 • Number of events 106 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
19.2%
143/745 • Number of events 176 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Anxiety
2.5%
2/79 • Number of events 2 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
11.3%
18/159 • Number of events 21 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
10.8%
45/417 • Number of events 55 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.4%
70/745 • Number of events 83 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Psychiatric disorders
Depression
2.5%
2/79 • Number of events 3 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
21/417 • Number of events 26 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.4%
40/745 • Number of events 51 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Infusion related reaction
3.8%
3/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.4%
15/159 • Number of events 24 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
9.6%
40/417 • Number of events 48 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.6%
49/745 • Number of events 61 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.5%
4/159 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
21/417 • Number of events 26 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.6%
42/745 • Number of events 47 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Proteinuria
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.3%
10/159 • Number of events 15 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.6%
36/417 • Number of events 78 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
8.1%
60/745 • Number of events 106 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Renal and urinary disorders
Dysuria
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 9 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.6%
15/417 • Number of events 19 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.6%
27/745 • Number of events 34 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Hypothyroidism
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.5%
27/417 • Number of events 32 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
20.1%
150/745 • Number of events 189 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Endocrine disorders
Hyperthyroidism
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.1%
5/159 • Number of events 5 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.9%
12/417 • Number of events 15 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.6%
42/745 • Number of events 47 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Palpitations
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.8%
6/159 • Number of events 7 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.2%
26/417 • Number of events 37 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
7.0%
52/745 • Number of events 62 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Tachycardia
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.5%
4/159 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.6%
15/417 • Number of events 20 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.8%
43/745 • Number of events 60 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Cardiac disorders
Atrial fibrillation
5.1%
4/79 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.00%
0/159 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
0.96%
4/417 • Number of events 4 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
1.2%
9/745 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Eye disorders
Vision blurred
1.3%
1/79 • Number of events 1 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.7%
9/159 • Number of events 10 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.9%
12/417 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.9%
44/745 • Number of events 47 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Drug hypersensitivity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
3.8%
6/159 • Number of events 6 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
5.0%
21/417 • Number of events 32 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.7%
20/745 • Number of events 25 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
Immune system disorders
Hypersensitivity
0.00%
0/79 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
6.9%
11/159 • Number of events 12 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.4%
10/417 • Number of events 13 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).
2.4%
18/745 • Number of events 23 • All-cause mortality, non-serious adverse event (SAEs) and SAEs were collected up to approximately 316 weeks.
All-cause mortality, non-serious adverse events (AEs), and serious adverse events (SAEs) were collected for all enrolled participants, including those who received only standard of care and no study intervention (not treated arm) and those who received at least one dose of a study intervention (arms 1, 2, and 3).

Additional Information

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Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER