Trial Outcomes & Findings for Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy (NCT NCT04655976)
NCT ID: NCT04655976
Last Updated: 2026-07-01
Results Overview
OS is defined as the time from the date of randomization to the date of death due to any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
758 participants
Primary outcome timeframe
Up to approximately 234 weeks
Results posted on
2026-07-01
Participant Flow
The results presented are based on primary completion date. Safety data collection (except ECG findings) is still ongoing, and additional results will be provided within a year of study completion.
Participant milestones
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Dostarlimab + Docetaxel (Arm B)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
305
|
301
|
152
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
305
|
301
|
152
|
|
Overall Study
Safety (SAF) Population
|
302
|
295
|
144
|
|
Overall Study
COMPLETED
|
227
|
236
|
116
|
|
Overall Study
NOT COMPLETED
|
78
|
65
|
36
|
Reasons for withdrawal
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Dostarlimab + Docetaxel (Arm B)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
16
|
13
|
|
Overall Study
Ongoing at the time of analysis
|
68
|
47
|
22
|
Baseline Characteristics
Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy
Baseline characteristics by cohort
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Dostarlimab + Docetaxel (Arm B)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Total
n=758 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 YEARS
STANDARD_DEVIATION 8.86 • n=9 Participants
|
64.3 YEARS
STANDARD_DEVIATION 9.85 • n=27 Participants
|
64.0 YEARS
STANDARD_DEVIATION 9.45 • n=267 Participants
|
64.0 YEARS
STANDARD_DEVIATION 9.37 • n=265 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=9 Participants
|
100 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
245 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=9 Participants
|
201 Participants
n=27 Participants
|
105 Participants
n=267 Participants
|
513 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
7 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Asian
|
37 Participants
n=9 Participants
|
44 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
105 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
White
|
245 Participants
n=9 Participants
|
224 Participants
n=27 Participants
|
119 Participants
n=267 Participants
|
588 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
11 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
27 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 234 weeksPopulation: Intent-to-Treat (ITT) population included all participants who were randomized into the study. As pre-specified in the protocol, the comparison of data was performed only between Arm A versus Arm C.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS) (Arm A Versus Arm C)
|
11.9 Months
Interval 10.6 to 14.2
|
11.3 Months
Interval 9.5 to 13.9
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 234 weeksPopulation: ITT population included all participants who were randomized into the study. As pre-specified in the protocol, the comparison of data was performed only between Arm B versus Arm C.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=301 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS) (Arm B Versus Arm C)
|
11.8 Months
Interval 10.3 to 12.9
|
11.3 Months
Interval 9.5 to 13.9
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 234 weeksPopulation: ITT population included all participants who were randomized into the study. As pre-specified in the protocol, the comparison of data was performed only between Arm A versus Arm B.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival (OS) (Arm A Versus Arm B)
|
11.9 Months
Interval 10.6 to 14.2
|
11.8 Months
Interval 10.3 to 12.9
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 234 weeksPopulation: ITT population
ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) as the best overall response based on Investigator assessment, evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 . PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
18.7 Percentage of participants
Interval 14.5 to 23.5
|
18.3 Percentage of participants
Interval 14.1 to 23.1
|
14.5 Percentage of participants
Interval 9.3 to 21.1
|
SECONDARY outcome
Timeframe: Up to approximately 234 weeksPopulation: ITT population
PFS is defined as the length of time from randomization to the earliest date of assessment of disease progression based on RECIST v1.1 by Investigator assessment or death by 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 has an absolute increase from nadir of 5 mm.)
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
4.4 Months
Interval 4.2 to 5.5
|
4.2 Months
Interval 4.0 to 5.4
|
4.1 Months
Interval 2.9 to 4.8
|
SECONDARY outcome
Timeframe: Up to approximately 234 weeksPopulation: ITT population. Only participants who achieved confirmed CR or PR as the best overall response is reported for this outcome measure.
DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). 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).
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=57 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=55 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=22 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
8.3 Months
Interval 6.2 to 9.9
|
7.1 Months
Interval 6.3 to 9.4
|
8.8 Months
Interval 5.1 to 11.0
|
SECONDARY outcome
Timeframe: Up to approximately 234 weeksPopulation: ITT population
TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC-QLQ-LC13).
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Time to Deterioration (TTD) in Lung Cancer
|
1.4 Months
Interval 1.2 to 1.5
|
1.4 Months
Interval 1.0 to 1.4
|
1.1 Months
Interval 0.8 to 1.4
|
SECONDARY outcome
Timeframe: Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)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 categories. Rows and Arms/Groups with 0 participants analyzed represent time points at which no participant data was available from within the respective Arms/Groups.
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning \[PF\], role functioning \[RF\], emotional functioning \[EF\] cognitive functioning \[CF\] and social functioning \[SF\]), three symptom scales (fatigue, nausea/vomiting \[N/V\] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss \[AL\], constipation, diarrhea and financial difficulties \[FD\]). Response options are 1 (Not at all) to 4 (Very much). 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. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C58D1
|
25.0 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C46D1
|
6.7 Scores on Scale
Standard Deviation 19.00
|
-8.3 Scores on Scale
Standard Deviation 11.79
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C50D1
|
10.0 Scores on Scale
Standard Deviation 22.36
|
-16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C54D1
|
2.8 Scores on Scale
Standard Deviation 22.15
|
0 Scores on Scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C58D1
|
-8.3 Scores on Scale
Standard Deviation 11.79
|
16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C66D1
|
—
|
-16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to EOT (~216 weeks)
|
-10.8 Scores on Scale
Standard Deviation 28.47
|
-9.3 Scores on Scale
Standard Deviation 28.76
|
-12.2 Scores on Scale
Standard Deviation 24.72
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to SFU D30(~220 weeks)
|
-7.3 Scores on Scale
Standard Deviation 25.88
|
-11.5 Scores on Scale
Standard Deviation 23.31
|
-6.9 Scores on Scale
Standard Deviation 28.20
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to SFU D90(~229 weeks)
|
-15.5 Scores on Scale
Standard Deviation 32.33
|
-12.3 Scores on Scale
Standard Deviation 30.66
|
-2.1 Scores on Scale
Standard Deviation 17.08
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C2D1
|
2.8 Scores on Scale
Standard Deviation 20.65
|
2.6 Scores on Scale
Standard Deviation 21.56
|
4.8 Scores on Scale
Standard Deviation 17.83
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C3D1
|
1.4 Scores on Scale
Standard Deviation 21.72
|
1.5 Scores on Scale
Standard Deviation 22.84
|
6.3 Scores on Scale
Standard Deviation 21.22
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C4D1
|
2.5 Scores on Scale
Standard Deviation 24.58
|
2.5 Scores on Scale
Standard Deviation 23.21
|
6.9 Scores on Scale
Standard Deviation 24.99
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C5D1
|
3.8 Scores on Scale
Standard Deviation 22.81
|
4.3 Scores on Scale
Standard Deviation 24.72
|
3.5 Scores on Scale
Standard Deviation 23.30
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C6D1
|
2.7 Scores on Scale
Standard Deviation 23.95
|
4.4 Scores on Scale
Standard Deviation 24.78
|
4.7 Scores on Scale
Standard Deviation 22.04
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C9D1
|
3.6 Scores on Scale
Standard Deviation 22.10
|
7.5 Scores on Scale
Standard Deviation 23.09
|
9.6 Scores on Scale
Standard Deviation 22.76
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C12D1
|
6.2 Scores on Scale
Standard Deviation 25.33
|
1.9 Scores on Scale
Standard Deviation 20.13
|
14.4 Scores on Scale
Standard Deviation 28.26
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C15D1
|
1.1 Scores on Scale
Standard Deviation 21.90
|
0.6 Scores on Scale
Standard Deviation 21.32
|
12.5 Scores on Scale
Standard Deviation 29.36
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C18D1
|
-0.3 Scores on Scale
Standard Deviation 22.29
|
3.0 Scores on Scale
Standard Deviation 19.78
|
2.8 Scores on Scale
Standard Deviation 10.64
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C22D1
|
3.8 Scores on Scale
Standard Deviation 21.46
|
-1.5 Scores on Scale
Standard Deviation 14.26
|
11.1 Scores on Scale
Standard Deviation 15.71
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C26D1
|
-2.0 Scores on Scale
Standard Deviation 22.63
|
2.0 Scores on Scale
Standard Deviation 20.87
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C30D1
|
2.1 Scores on Scale
Standard Deviation 23.52
|
-0.8 Scores on Scale
Standard Deviation 20.19
|
-11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C34D1
|
-4.7 Scores on Scale
Standard Deviation 17.10
|
1.6 Scores on Scale
Standard Deviation 23.51
|
-11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C38D1
|
-0.9 Scores on Scale
Standard Deviation 28.13
|
0 Scores on Scale
Standard Deviation 7.03
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C42D1
|
-11.1 Scores on Scale
Standard Deviation 15.71
|
11.1 Scores on Scale
Standard Deviation 20.29
|
-11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C46D1
|
-8.9 Scores on Scale
Standard Deviation 9.30
|
5.6 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C50D1
|
-13.3 Scores on Scale
Standard Deviation 12.17
|
-11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C54D1
|
-11.1 Scores on Scale
Standard Deviation 15.71
|
-11.1 Scores on Scale
Standard Deviation 31.43
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C62D1
|
-5.6 Scores on Scale
Standard Deviation 7.86
|
11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to C66D1
|
—
|
22.2 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to EOT (~216 weeks)
|
13.9 Scores on Scale
Standard Deviation 26.45
|
12.4 Scores on Scale
Standard Deviation 23.75
|
12.6 Scores on Scale
Standard Deviation 28.62
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to SFU D30(~220 weeks)
|
11.5 Scores on Scale
Standard Deviation 23.65
|
10.0 Scores on Scale
Standard Deviation 17.25
|
8.8 Scores on Scale
Standard Deviation 23.85
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Fatigue, CFB to SFUP D90(~229 weeks)
|
6.3 Scores on Scale
Standard Deviation 28.81
|
15.5 Scores on Scale
Standard Deviation 20.03
|
1.4 Scores on Scale
Standard Deviation 21.03
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C2D1
|
1.4 Scores on Scale
Standard Deviation 14.61
|
1.2 Scores on Scale
Standard Deviation 18.07
|
0.3 Scores on Scale
Standard Deviation 15.33
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C3D1
|
1.0 Scores on Scale
Standard Deviation 15.49
|
1.5 Scores on Scale
Standard Deviation 16.46
|
2.7 Scores on Scale
Standard Deviation 15.13
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C4D1
|
-0.5 Scores on Scale
Standard Deviation 13.00
|
0.9 Scores on Scale
Standard Deviation 16.22
|
1.1 Scores on Scale
Standard Deviation 14.16
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C5D1
|
1.6 Scores on Scale
Standard Deviation 15.58
|
1.9 Scores on Scale
Standard Deviation 16.35
|
0.9 Scores on Scale
Standard Deviation 13.88
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C6D1
|
0 Scores on Scale
Standard Deviation 13.04
|
1.0 Scores on Scale
Standard Deviation 13.42
|
-2.2 Scores on Scale
Standard Deviation 10.96
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C9D1
|
-0.5 Scores on Scale
Standard Deviation 13.63
|
3.3 Scores on Scale
Standard Deviation 17.40
|
0.6 Scores on Scale
Standard Deviation 10.43
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C12D1
|
1.8 Scores on Scale
Standard Deviation 14.90
|
0.3 Scores on Scale
Standard Deviation 10.94
|
5.9 Scores on Scale
Standard Deviation 11.70
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C15D1
|
-0.6 Scores on Scale
Standard Deviation 13.60
|
-0.9 Scores on Scale
Standard Deviation 10.78
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C18D1
|
0.4 Scores on Scale
Standard Deviation 15.21
|
0 Scores on Scale
Standard Deviation 11.58
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C22D1
|
-0.8 Scores on Scale
Standard Deviation 16.65
|
-0.8 Scores on Scale
Standard Deviation 10.88
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C26D1
|
-3.4 Scores on Scale
Standard Deviation 17.30
|
2.0 Scores on Scale
Standard Deviation 13.02
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C30D1
|
-3.8 Scores on Scale
Standard Deviation 18.44
|
2.4 Scores on Scale
Standard Deviation 14.41
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C34D1
|
-1.8 Scores on Scale
Standard Deviation 13.49
|
0 Scores on Scale
Standard Deviation 19.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C38D1
|
-1.3 Scores on Scale
Standard Deviation 15.90
|
-2.8 Scores on Scale
Standard Deviation 22.15
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C42D1
|
-4.2 Scores on Scale
Standard Deviation 21.36
|
4.2 Scores on Scale
Standard Deviation 20.97
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C46D1
|
-10.0 Scores on Scale
Standard Deviation 22.36
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C50D1
|
-6.7 Scores on Scale
Standard Deviation 25.28
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C54D1
|
-8.3 Scores on Scale
Standard Deviation 20.41
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C62D1
|
25.0 Scores on Scale
Standard Deviation 35.36
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to C66D1
|
—
|
16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to EOT (~216 weeks)
|
4.8 Scores on Scale
Standard Deviation 17.24
|
3.1 Scores on Scale
Standard Deviation 19.79
|
5.0 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to SFU D30(~220 weeks)
|
4.3 Scores on Scale
Standard Deviation 14.67
|
-1.3 Scores on Scale
Standard Deviation 12.32
|
0.7 Scores on Scale
Standard Deviation 14.31
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
N/V, CFB to SFUP D90(~229 weeks)
|
-2.4 Scores on Scale
Standard Deviation 11.05
|
2.9 Scores on Scale
Standard Deviation 19.24
|
-1.0 Scores on Scale
Standard Deviation 15.48
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C2D1
|
-3.5 Scores on Scale
Standard Deviation 23.49
|
-3.9 Scores on Scale
Standard Deviation 25.66
|
3.0 Scores on Scale
Standard Deviation 24.11
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C3D1
|
-6.4 Scores on Scale
Standard Deviation 23.63
|
-2.7 Scores on Scale
Standard Deviation 27.45
|
3.5 Scores on Scale
Standard Deviation 25.62
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C4D1
|
-2.9 Scores on Scale
Standard Deviation 27.29
|
-3.5 Scores on Scale
Standard Deviation 26.49
|
1.8 Scores on Scale
Standard Deviation 23.82
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C5D1
|
-1.0 Scores on Scale
Standard Deviation 25.49
|
-2.5 Scores on Scale
Standard Deviation 25.27
|
-1.5 Scores on Scale
Standard Deviation 17.90
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C6D1
|
-3.5 Scores on Scale
Standard Deviation 26.53
|
-1.8 Scores on Scale
Standard Deviation 24.23
|
-0.3 Scores on Scale
Standard Deviation 18.52
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C9D1
|
0.7 Scores on Scale
Standard Deviation 23.20
|
-3.7 Scores on Scale
Standard Deviation 27.74
|
6.3 Scores on Scale
Standard Deviation 19.63
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C12D1
|
5.3 Scores on Scale
Standard Deviation 24.84
|
2.5 Scores on Scale
Standard Deviation 26.95
|
12.7 Scores on Scale
Standard Deviation 29.77
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C15D1
|
1.1 Scores on Scale
Standard Deviation 19.96
|
0.9 Scores on Scale
Standard Deviation 27.02
|
8.3 Scores on Scale
Standard Deviation 25.20
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C18D1
|
4.3 Scores on Scale
Standard Deviation 18.58
|
3.9 Scores on Scale
Standard Deviation 27.22
|
8.3 Scores on Scale
Standard Deviation 9.62
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C22D1
|
3.3 Scores on Scale
Standard Deviation 17.17
|
-4.5 Scores on Scale
Standard Deviation 25.29
|
16.7 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C26D1
|
0.5 Scores on Scale
Standard Deviation 21.90
|
-1.0 Scores on Scale
Standard Deviation 19.07
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C30D1
|
5.8 Scores on Scale
Standard Deviation 19.40
|
-8.3 Scores on Scale
Standard Deviation 25.94
|
16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C34D1
|
2.6 Scores on Scale
Standard Deviation 17.80
|
0 Scores on Scale
Standard Deviation 19.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C38D1
|
9.0 Scores on Scale
Standard Deviation 17.50
|
-5.6 Scores on Scale
Standard Deviation 25.09
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C42D1
|
6.3 Scores on Scale
Standard Deviation 17.68
|
0 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C46D1
|
10.0 Scores on Scale
Standard Deviation 19.00
|
-8.3 Scores on Scale
Standard Deviation 11.79
|
16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C50D1
|
13.3 Scores on Scale
Standard Deviation 13.94
|
-16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C54D1
|
5.6 Scores on Scale
Standard Deviation 13.61
|
-8.3 Scores on Scale
Standard Deviation 11.79
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C58D1
|
16.7 Scores on Scale
Standard Deviation 0
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C62D1
|
16.7 Scores on Scale
Standard Deviation 23.57
|
-16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to EOT (~216 weeks)
|
9.4 Scores on Scale
Standard Deviation 30.37
|
10.9 Scores on Scale
Standard Deviation 29.98
|
10.4 Scores on Scale
Standard Deviation 30.96
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to SFU D30(~220 weeks)
|
9.8 Scores on Scale
Standard Deviation 23.17
|
6.0 Scores on Scale
Standard Deviation 20.41
|
6.3 Scores on Scale
Standard Deviation 29.00
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Pain, CFB to SFU D90(~229 weeks)
|
4.8 Scores on Scale
Standard Deviation 31.64
|
5.1 Scores on Scale
Standard Deviation 32.35
|
2.1 Scores on Scale
Standard Deviation 20.07
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C2D1
|
-1.7 Scores on Scale
Standard Deviation 23.96
|
-1.1 Scores on Scale
Standard Deviation 26.64
|
1.9 Scores on Scale
Standard Deviation 24.17
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C3D1
|
-3.0 Scores on Scale
Standard Deviation 26.78
|
-0.5 Scores on Scale
Standard Deviation 27.25
|
3.2 Scores on Scale
Standard Deviation 26.80
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C4D1
|
0.9 Scores on Scale
Standard Deviation 27.96
|
0.8 Scores on Scale
Standard Deviation 25.99
|
6.3 Scores on Scale
Standard Deviation 27.96
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C5D1
|
2.0 Scores on Scale
Standard Deviation 30.02
|
1.3 Scores on Scale
Standard Deviation 26.81
|
2.9 Scores on Scale
Standard Deviation 25.42
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C6D1
|
-0.2 Scores on Scale
Standard Deviation 27.63
|
2.1 Scores on Scale
Standard Deviation 23.79
|
3.8 Scores on Scale
Standard Deviation 26.94
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C9D1
|
1.3 Scores on Scale
Standard Deviation 29.03
|
4.3 Scores on Scale
Standard Deviation 26.12
|
13.8 Scores on Scale
Standard Deviation 28.89
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C12D1
|
0.9 Scores on Scale
Standard Deviation 27.93
|
-4.5 Scores on Scale
Standard Deviation 25.11
|
21.6 Scores on Scale
Standard Deviation 28.73
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C15D1
|
-1.7 Scores on Scale
Standard Deviation 20.16
|
-6.1 Scores on Scale
Standard Deviation 24.33
|
25.0 Scores on Scale
Standard Deviation 38.83
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C18D1
|
1.6 Scores on Scale
Standard Deviation 24.07
|
-7.8 Scores on Scale
Standard Deviation 22.63
|
8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C22D1
|
0.8 Scores on Scale
Standard Deviation 25.26
|
-3.0 Scores on Scale
Standard Deviation 22.79
|
16.7 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C26D1
|
0 Scores on Scale
Standard Deviation 34.36
|
10.4 Scores on Scale
Standard Deviation 26.44
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C30D1
|
0 Scores on Scale
Standard Deviation 28.28
|
2.4 Scores on Scale
Standard Deviation 20.52
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C34D1
|
-5.3 Scores on Scale
Standard Deviation 33.82
|
0 Scores on Scale
Standard Deviation 27.22
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C38D1
|
-10.3 Scores on Scale
Standard Deviation 25.04
|
5.6 Scores on Scale
Standard Deviation 25.09
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C42D1
|
-4.2 Scores on Scale
Standard Deviation 11.79
|
16.7 Scores on Scale
Standard Deviation 33.33
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C46D1
|
6.7 Scores on Scale
Standard Deviation 14.91
|
33.3 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C54D1
|
-5.6 Scores on Scale
Standard Deviation 25.09
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C58D1
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C62D1
|
-33.3 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to C66D1
|
—
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to EOT (~216 weeks)
|
11.4 Scores on Scale
Standard Deviation 30.74
|
11.6 Scores on Scale
Standard Deviation 32.88
|
12.1 Scores on Scale
Standard Deviation 30.74
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to SFU D30(~220 weeks)
|
9.4 Scores on Scale
Standard Deviation 33.29
|
8.5 Scores on Scale
Standard Deviation 36.45
|
6.9 Scores on Scale
Standard Deviation 29.45
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Dyspnea, CFB to SFU D90(~229 weeks)
|
-9.5 Scores on Scale
Standard Deviation 27.51
|
33.3 Scores on Scale
Standard Deviation 37.61
|
2.1 Scores on Scale
Standard Deviation 33.26
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C2D1
|
-3.3 Scores on Scale
Standard Deviation 25.83
|
-2.7 Scores on Scale
Standard Deviation 30.24
|
-1.0 Scores on Scale
Standard Deviation 30.82
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C3D1
|
-7.9 Scores on Scale
Standard Deviation 25.33
|
0.2 Scores on Scale
Standard Deviation 31.76
|
0.4 Scores on Scale
Standard Deviation 30.72
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C4D1
|
-6.6 Scores on Scale
Standard Deviation 26.51
|
-0.6 Scores on Scale
Standard Deviation 30.29
|
0.5 Scores on Scale
Standard Deviation 32.40
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C5D1
|
-4.5 Scores on Scale
Standard Deviation 28.81
|
0.3 Scores on Scale
Standard Deviation 32.41
|
2.3 Scores on Scale
Standard Deviation 30.12
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C6D1
|
-4.3 Scores on Scale
Standard Deviation 28.03
|
-1.8 Scores on Scale
Standard Deviation 30.16
|
-1.3 Scores on Scale
Standard Deviation 33.63
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C9D1
|
-5.3 Scores on Scale
Standard Deviation 25.70
|
1.2 Scores on Scale
Standard Deviation 33.11
|
-1.1 Scores on Scale
Standard Deviation 20.86
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C12D1
|
-0.9 Scores on Scale
Standard Deviation 26.83
|
1.1 Scores on Scale
Standard Deviation 33.88
|
3.9 Scores on Scale
Standard Deviation 26.04
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C15D1
|
-3.4 Scores on Scale
Standard Deviation 23.93
|
-5.1 Scores on Scale
Standard Deviation 28.14
|
8.3 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C18D1
|
2.3 Scores on Scale
Standard Deviation 23.45
|
4.4 Scores on Scale
Standard Deviation 31.24
|
8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C22D1
|
1.6 Scores on Scale
Standard Deviation 21.02
|
-4.5 Scores on Scale
Standard Deviation 27.78
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C26D1
|
-2.9 Scores on Scale
Standard Deviation 23.74
|
-3.9 Scores on Scale
Standard Deviation 30.92
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C30D1
|
-3.8 Scores on Scale
Standard Deviation 17.20
|
2.4 Scores on Scale
Standard Deviation 33.24
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C34D1
|
-3.5 Scores on Scale
Standard Deviation 15.29
|
28.6 Scores on Scale
Standard Deviation 35.63
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C38D1
|
-2.6 Scores on Scale
Standard Deviation 9.25
|
11.1 Scores on Scale
Standard Deviation 34.43
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C42D1
|
4.2 Scores on Scale
Standard Deviation 21.36
|
33.3 Scores on Scale
Standard Deviation 27.22
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C46D1
|
6.7 Scores on Scale
Standard Deviation 36.51
|
50.0 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C50D1
|
6.7 Scores on Scale
Standard Deviation 14.91
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C54D1
|
0 Scores on Scale
Standard Deviation 21.08
|
33.3 Scores on Scale
Standard Deviation 47.14
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C58D1
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to C66D1
|
—
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to EOT (~216 weeks)
|
5.6 Scores on Scale
Standard Deviation 31.44
|
6.5 Scores on Scale
Standard Deviation 32.44
|
1.0 Scores on Scale
Standard Deviation 35.76
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to SFU D30(~220 weeks)
|
-5.3 Scores on Scale
Standard Deviation 31.51
|
2.6 Scores on Scale
Standard Deviation 29.00
|
1.4 Scores on Scale
Standard Deviation 30.26
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Insomnia, CFB to SFU D90(~229 weeks)
|
4.8 Scores on Scale
Standard Deviation 31.64
|
1.4 Scores on Scale
Standard Deviation 34.05
|
-14.6 Scores on Scale
Standard Deviation 34.36
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C2D1
|
1.9 Scores on Scale
Standard Deviation 28.68
|
1.9 Scores on Scale
Standard Deviation 28.23
|
5.4 Scores on Scale
Standard Deviation 25.79
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C3D1
|
-2.1 Scores on Scale
Standard Deviation 28.42
|
3.1 Scores on Scale
Standard Deviation 31.03
|
5.4 Scores on Scale
Standard Deviation 27.64
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C4D1
|
-0.7 Scores on Scale
Standard Deviation 26.84
|
-0.2 Scores on Scale
Standard Deviation 27.68
|
3.2 Scores on Scale
Standard Deviation 32.25
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C5D1
|
3.7 Scores on Scale
Standard Deviation 29.02
|
-0.8 Scores on Scale
Standard Deviation 32.93
|
2.9 Scores on Scale
Standard Deviation 27.66
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C6D1
|
1.8 Scores on Scale
Standard Deviation 27.90
|
-1.8 Scores on Scale
Standard Deviation 30.16
|
-1.9 Scores on Scale
Standard Deviation 25.92
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C9D1
|
-3.0 Scores on Scale
Standard Deviation 26.42
|
3.5 Scores on Scale
Standard Deviation 33.34
|
3.4 Scores on Scale
Standard Deviation 22.44
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C12D1
|
6.2 Scores on Scale
Standard Deviation 28.84
|
3.4 Scores on Scale
Standard Deviation 33.16
|
5.9 Scores on Scale
Standard Deviation 21.20
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C15D1
|
1.7 Scores on Scale
Standard Deviation 29.57
|
3.4 Scores on Scale
Standard Deviation 25.13
|
0 Scores on Scale
Standard Deviation 17.82
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C18D1
|
-3.9 Scores on Scale
Standard Deviation 31.88
|
0 Scores on Scale
Standard Deviation 29.03
|
0 Scores on Scale
Standard Deviation 27.22
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C22D1
|
6.5 Scores on Scale
Standard Deviation 29.08
|
-3.0 Scores on Scale
Standard Deviation 25.01
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C26D1
|
-2.9 Scores on Scale
Standard Deviation 34.20
|
2.0 Scores on Scale
Standard Deviation 24.92
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C30D1
|
-3.8 Scores on Scale
Standard Deviation 33.10
|
-2.4 Scores on Scale
Standard Deviation 24.33
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C34D1
|
0 Scores on Scale
Standard Deviation 31.43
|
-9.5 Scores on Scale
Standard Deviation 37.09
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C38D1
|
-2.6 Scores on Scale
Standard Deviation 34.59
|
11.1 Scores on Scale
Standard Deviation 17.21
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C42D1
|
0 Scores on Scale
Standard Deviation 30.86
|
8.3 Scores on Scale
Standard Deviation 16.67
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C46D1
|
-6.7 Scores on Scale
Standard Deviation 36.51
|
0 Scores on Scale
Standard Deviation 0
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 40.82
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C54D1
|
-16.7 Scores on Scale
Standard Deviation 40.82
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C58D1
|
-33.3 Scores on Scale
Standard Deviation 47.14
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to EOT (~216 weeks)
|
12.1 Scores on Scale
Standard Deviation 31.90
|
8.0 Scores on Scale
Standard Deviation 34.78
|
9.0 Scores on Scale
Standard Deviation 30.47
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to SFU D30(~220 weeks)
|
5.3 Scores on Scale
Standard Deviation 32.44
|
3.4 Scores on Scale
Standard Deviation 23.93
|
0 Scores on Scale
Standard Deviation 24.08
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
AL, CFB to SFU D90(~229 weeks)
|
-7.1 Scores on Scale
Standard Deviation 41.71
|
10.1 Scores on Scale
Standard Deviation 29.19
|
-4.2 Scores on Scale
Standard Deviation 23.96
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C2D1
|
-0.9 Scores on Scale
Standard Deviation 21.87
|
-2.4 Scores on Scale
Standard Deviation 25.34
|
-1.3 Scores on Scale
Standard Deviation 25.29
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C3D1
|
-0.3 Scores on Scale
Standard Deviation 20.92
|
-0.4 Scores on Scale
Standard Deviation 26.69
|
-1.4 Scores on Scale
Standard Deviation 25.83
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C4D1
|
-0.7 Scores on Scale
Standard Deviation 21.79
|
-5.0 Scores on Scale
Standard Deviation 27.44
|
1.8 Scores on Scale
Standard Deviation 29.14
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C5D1
|
0.8 Scores on Scale
Standard Deviation 21.58
|
-2.8 Scores on Scale
Standard Deviation 25.01
|
0 Scores on Scale
Standard Deviation 30.86
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C6D1
|
-2.0 Scores on Scale
Standard Deviation 24.66
|
-3.5 Scores on Scale
Standard Deviation 26.11
|
-4.5 Scores on Scale
Standard Deviation 25.59
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C9D1
|
0.7 Scores on Scale
Standard Deviation 21.07
|
-3.5 Scores on Scale
Standard Deviation 30.87
|
2.3 Scores on Scale
Standard Deviation 25.09
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C12D1
|
0.4 Scores on Scale
Standard Deviation 21.57
|
-4.5 Scores on Scale
Standard Deviation 28.67
|
9.8 Scores on Scale
Standard Deviation 15.66
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C15D1
|
-0.6 Scores on Scale
Standard Deviation 20.22
|
-10.3 Scores on Scale
Standard Deviation 28.77
|
4.2 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C18D1
|
-1.6 Scores on Scale
Standard Deviation 22.95
|
-13.3 Scores on Scale
Standard Deviation 27.12
|
8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C22D1
|
-3.3 Scores on Scale
Standard Deviation 22.12
|
-7.6 Scores on Scale
Standard Deviation 22.84
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C26D1
|
1.0 Scores on Scale
Standard Deviation 17.38
|
-7.8 Scores on Scale
Standard Deviation 27.71
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C30D1
|
-1.3 Scores on Scale
Standard Deviation 19.96
|
-4.8 Scores on Scale
Standard Deviation 31.64
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C34D1
|
-1.8 Scores on Scale
Standard Deviation 17.48
|
0 Scores on Scale
Standard Deviation 27.22
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C38D1
|
-7.7 Scores on Scale
Standard Deviation 14.62
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C42D1
|
0 Scores on Scale
Standard Deviation 17.82
|
8.3 Scores on Scale
Standard Deviation 31.91
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C46D1
|
-6.7 Scores on Scale
Standard Deviation 14.91
|
33.3 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C50D1
|
-6.7 Scores on Scale
Standard Deviation 14.91
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C54D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C58D1
|
16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to C66D1
|
—
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to EOT (~216 weeks)
|
6.1 Scores on Scale
Standard Deviation 25.09
|
-4.3 Scores on Scale
Standard Deviation 30.09
|
3.0 Scores on Scale
Standard Deviation 27.67
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to SFU D30(~220 weeks)
|
1.7 Scores on Scale
Standard Deviation 28.56
|
-8.5 Scores on Scale
Standard Deviation 28.32
|
-6.9 Scores on Scale
Standard Deviation 27.77
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Constipation, CFB to SFU D90(~229 weeks)
|
11.9 Scores on Scale
Standard Deviation 28.06
|
-8.7 Scores on Scale
Standard Deviation 27.00
|
-8.3 Scores on Scale
Standard Deviation 22.77
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C2D1
|
2.1 Scores on Scale
Standard Deviation 18.05
|
3.5 Scores on Scale
Standard Deviation 21.29
|
4.1 Scores on Scale
Standard Deviation 18.31
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C3D1
|
2.5 Scores on Scale
Standard Deviation 17.18
|
4.3 Scores on Scale
Standard Deviation 17.87
|
5.0 Scores on Scale
Standard Deviation 19.53
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C4D1
|
2.5 Scores on Scale
Standard Deviation 17.06
|
3.7 Scores on Scale
Standard Deviation 18.26
|
3.2 Scores on Scale
Standard Deviation 14.77
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C5D1
|
3.9 Scores on Scale
Standard Deviation 17.08
|
2.1 Scores on Scale
Standard Deviation 18.59
|
1.8 Scores on Scale
Standard Deviation 17.16
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C6D1
|
3.6 Scores on Scale
Standard Deviation 16.56
|
2.9 Scores on Scale
Standard Deviation 18.13
|
1.9 Scores on Scale
Standard Deviation 15.36
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C9D1
|
3.6 Scores on Scale
Standard Deviation 18.80
|
2.4 Scores on Scale
Standard Deviation 17.66
|
8.0 Scores on Scale
Standard Deviation 21.19
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C12D1
|
1.8 Scores on Scale
Standard Deviation 18.90
|
3.4 Scores on Scale
Standard Deviation 18.41
|
2.0 Scores on Scale
Standard Deviation 14.29
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C15D1
|
-1.7 Scores on Scale
Standard Deviation 14.54
|
-2.6 Scores on Scale
Standard Deviation 11.81
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C18D1
|
3.9 Scores on Scale
Standard Deviation 14.92
|
-6.7 Scores on Scale
Standard Deviation 16.14
|
8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C22D1
|
-0.8 Scores on Scale
Standard Deviation 13.92
|
-6.1 Scores on Scale
Standard Deviation 16.70
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C26D1
|
1.0 Scores on Scale
Standard Deviation 15.32
|
-5.9 Scores on Scale
Standard Deviation 17.62
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C30D1
|
-2.6 Scores on Scale
Standard Deviation 13.07
|
-2.4 Scores on Scale
Standard Deviation 15.82
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C34D1
|
1.8 Scores on Scale
Standard Deviation 17.48
|
-4.8 Scores on Scale
Standard Deviation 12.60
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C38D1
|
-2.6 Scores on Scale
Standard Deviation 16.45
|
0 Scores on Scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C42D1
|
0 Scores on Scale
Standard Deviation 0
|
8.3 Scores on Scale
Standard Deviation 16.67
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C46D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C54D1
|
5.6 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C62D1
|
16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to EOT (~216 weeks)
|
4.8 Scores on Scale
Standard Deviation 22.20
|
2.9 Scores on Scale
Standard Deviation 20.72
|
4.5 Scores on Scale
Standard Deviation 18.25
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to SFU D30(~220 weeks)
|
4.3 Scores on Scale
Standard Deviation 21.87
|
7.7 Scores on Scale
Standard Deviation 16.15
|
1.4 Scores on Scale
Standard Deviation 15.48
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Diarrhea, CFB to SFU D90(~229 weeks)
|
-2.4 Scores on Scale
Standard Deviation 20.52
|
2.9 Scores on Scale
Standard Deviation 26.43
|
-2.1 Scores on Scale
Standard Deviation 8.33
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C2D1
|
-2.5 Scores on Scale
Standard Deviation 23.44
|
-1.7 Scores on Scale
Standard Deviation 22.17
|
2.5 Scores on Scale
Standard Deviation 20.51
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C3D1
|
0.3 Scores on Scale
Standard Deviation 24.31
|
-1.6 Scores on Scale
Standard Deviation 22.66
|
2.9 Scores on Scale
Standard Deviation 20.17
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C4D1
|
-1.4 Scores on Scale
Standard Deviation 22.68
|
0.2 Scores on Scale
Standard Deviation 22.82
|
2.7 Scores on Scale
Standard Deviation 24.52
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C5D1
|
0.8 Scores on Scale
Standard Deviation 23.04
|
-0.5 Scores on Scale
Standard Deviation 24.48
|
-1.2 Scores on Scale
Standard Deviation 21.99
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C6D1
|
1.4 Scores on Scale
Standard Deviation 21.61
|
1.5 Scores on Scale
Standard Deviation 20.11
|
-1.9 Scores on Scale
Standard Deviation 16.72
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C9D1
|
1.3 Scores on Scale
Standard Deviation 22.07
|
5.1 Scores on Scale
Standard Deviation 28.41
|
-1.1 Scores on Scale
Standard Deviation 18.86
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C12D1
|
-0.4 Scores on Scale
Standard Deviation 24.19
|
0 Scores on Scale
Standard Deviation 21.63
|
-2.0 Scores on Scale
Standard Deviation 14.29
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C15D1
|
0 Scores on Scale
Standard Deviation 24.98
|
2.6 Scores on Scale
Standard Deviation 23.43
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C18D1
|
-0.8 Scores on Scale
Standard Deviation 17.04
|
1.1 Scores on Scale
Standard Deviation 22.29
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C22D1
|
5.7 Scores on Scale
Standard Deviation 26.77
|
3.0 Scores on Scale
Standard Deviation 17.55
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C26D1
|
1.0 Scores on Scale
Standard Deviation 23.90
|
2.0 Scores on Scale
Standard Deviation 18.52
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C30D1
|
3.8 Scores on Scale
Standard Deviation 17.20
|
4.8 Scores on Scale
Standard Deviation 25.68
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C34D1
|
-1.8 Scores on Scale
Standard Deviation 17.48
|
9.5 Scores on Scale
Standard Deviation 31.71
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C38D1
|
0 Scores on Scale
Standard Deviation 23.57
|
11.1 Scores on Scale
Standard Deviation 34.43
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C42D1
|
4.2 Scores on Scale
Standard Deviation 45.21
|
8.3 Scores on Scale
Standard Deviation 31.91
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C46D1
|
0 Scores on Scale
Standard Deviation 40.82
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C50D1
|
-6.7 Scores on Scale
Standard Deviation 36.51
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C54D1
|
11.1 Scores on Scale
Standard Deviation 34.43
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
-33.3 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to EOT (~216 weeks)
|
5.8 Scores on Scale
Standard Deviation 27.67
|
7.1 Scores on Scale
Standard Deviation 26.64
|
5.5 Scores on Scale
Standard Deviation 26.97
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to SFU D30(~220 weeks)
|
1.7 Scores on Scale
Standard Deviation 28.56
|
5.1 Scores on Scale
Standard Deviation 23.62
|
-4.2 Scores on Scale
Standard Deviation 26.58
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
FD, CFB to SFU D90(~229 weeks)
|
0 Scores on Scale
Standard Deviation 22.65
|
2.9 Scores on Scale
Standard Deviation 26.43
|
8.3 Scores on Scale
Standard Deviation 25.82
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C2D1
|
1.0 Scores on Scale
Standard Deviation 17.62
|
-0.3 Scores on Scale
Standard Deviation 20.06
|
-0.3 Scores on Scale
Standard Deviation 16.42
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C3D1
|
0.3 Scores on Scale
Standard Deviation 20.32
|
0.5 Scores on Scale
Standard Deviation 19.75
|
-2.8 Scores on Scale
Standard Deviation 16.98
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C4D1
|
-0.4 Scores on Scale
Standard Deviation 19.43
|
-0.7 Scores on Scale
Standard Deviation 21.06
|
-4.7 Scores on Scale
Standard Deviation 21.56
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C5D1
|
-1.5 Scores on Scale
Standard Deviation 19.26
|
-0.5 Scores on Scale
Standard Deviation 20.53
|
0.2 Scores on Scale
Standard Deviation 19.07
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C6D1
|
-1.3 Scores on Scale
Standard Deviation 20.79
|
-1.5 Scores on Scale
Standard Deviation 20.31
|
-8.5 Scores on Scale
Standard Deviation 21.19
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C9D1
|
-1.2 Scores on Scale
Standard Deviation 18.16
|
0.4 Scores on Scale
Standard Deviation 19.97
|
-10.4 Scores on Scale
Standard Deviation 19.28
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C12D1
|
-4.1 Scores on Scale
Standard Deviation 18.94
|
-1.0 Scores on Scale
Standard Deviation 20.97
|
-9.8 Scores on Scale
Standard Deviation 24.95
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C15D1
|
-0.9 Scores on Scale
Standard Deviation 12.18
|
0 Scores on Scale
Standard Deviation 18.84
|
-15.0 Scores on Scale
Standard Deviation 17.08
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C18D1
|
-2.4 Scores on Scale
Standard Deviation 13.60
|
-2.6 Scores on Scale
Standard Deviation 17.27
|
-8.3 Scores on Scale
Standard Deviation 14.43
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C22D1
|
-1.8 Scores on Scale
Standard Deviation 17.24
|
-5.0 Scores on Scale
Standard Deviation 15.15
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C26D1
|
-1.3 Scores on Scale
Standard Deviation 15.71
|
-8.9 Scores on Scale
Standard Deviation 16.51
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C30D1
|
1.0 Scores on Scale
Standard Deviation 15.41
|
4.5 Scores on Scale
Standard Deviation 18.20
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C34D1
|
-2.3 Scores on Scale
Standard Deviation 11.00
|
4.8 Scores on Scale
Standard Deviation 16.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C38D1
|
-9.0 Scores on Scale
Standard Deviation 18.47
|
-13.9 Scores on Scale
Standard Deviation 38.25
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C42D1
|
1.0 Scores on Scale
Standard Deviation 19.13
|
-2.1 Scores on Scale
Standard Deviation 10.49
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C46D1
|
0 Scores on Scale
Standard Deviation 22.82
|
-4.2 Scores on Scale
Standard Deviation 5.89
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C50D1
|
-1.7 Scores on Scale
Standard Deviation 26.61
|
8.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C54D1
|
1.4 Scores on Scale
Standard Deviation 14.35
|
-16.7 Scores on Scale
Standard Deviation 11.79
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C58D1
|
12.5 Scores on Scale
Standard Deviation 5.89
|
-8.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C62D1
|
-4.2 Scores on Scale
Standard Deviation 5.89
|
-8.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to C66D1
|
—
|
8.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to EoT (~216 weeks)
|
-10.7 Scores on Scale
Standard Deviation 24.09
|
-9.3 Scores on Scale
Standard Deviation 20.16
|
-11.6 Scores on Scale
Standard Deviation 21.11
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to SFU D30 (~220 weeks)
|
-9.4 Scores on Scale
Standard Deviation 16.80
|
-6.8 Scores on Scale
Standard Deviation 15.07
|
-7.5 Scores on Scale
Standard Deviation 21.72
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
GHS/QoL, CFB to SFU D90 (~229 weeks)
|
-7.7 Scores on Scale
Standard Deviation 21.30
|
-13.6 Scores on Scale
Standard Deviation 21.45
|
-2.6 Scores on Scale
Standard Deviation 15.73
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C2D1
|
-1.8 Scores on Scale
Standard Deviation 14.58
|
-0.9 Scores on Scale
Standard Deviation 15.44
|
-2.5 Scores on Scale
Standard Deviation 15.23
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C3D1
|
-0.1 Scores on Scale
Standard Deviation 14.17
|
-0.9 Scores on Scale
Standard Deviation 15.74
|
-3.2 Scores on Scale
Standard Deviation 17.61
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C4D1
|
-1.7 Scores on Scale
Standard Deviation 16.61
|
-3.9 Scores on Scale
Standard Deviation 16.30
|
-4.1 Scores on Scale
Standard Deviation 17.48
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C5D1
|
-5.3 Scores on Scale
Standard Deviation 18.13
|
-3.4 Scores on Scale
Standard Deviation 18.83
|
-5.0 Scores on Scale
Standard Deviation 16.00
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C6D1
|
-3.0 Scores on Scale
Standard Deviation 19.62
|
-3.8 Scores on Scale
Standard Deviation 17.61
|
-6.2 Scores on Scale
Standard Deviation 15.89
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C9D1
|
-2.4 Scores on Scale
Standard Deviation 17.48
|
-3.3 Scores on Scale
Standard Deviation 18.67
|
-9.0 Scores on Scale
Standard Deviation 15.56
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C12D1
|
-4.8 Scores on Scale
Standard Deviation 17.10
|
-2.1 Scores on Scale
Standard Deviation 15.00
|
-17.3 Scores on Scale
Standard Deviation 19.87
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C15D1
|
-2.8 Scores on Scale
Standard Deviation 16.19
|
-2.6 Scores on Scale
Standard Deviation 20.35
|
-16.7 Scores on Scale
Standard Deviation 20.47
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C18D1
|
-0.6 Scores on Scale
Standard Deviation 13.94
|
-3.1 Scores on Scale
Standard Deviation 14.51
|
-13.3 Scores on Scale
Standard Deviation 18.05
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C22D1
|
-4.2 Scores on Scale
Standard Deviation 18.84
|
-2.4 Scores on Scale
Standard Deviation 17.88
|
-16.7 Scores on Scale
Standard Deviation 4.71
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C26D1
|
-3.3 Scores on Scale
Standard Deviation 25.07
|
-0.8 Scores on Scale
Standard Deviation 15.61
|
6.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C30D1
|
-0.5 Scores on Scale
Standard Deviation 23.47
|
-2.4 Scores on Scale
Standard Deviation 16.04
|
-6.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C34D1
|
2.8 Scores on Scale
Standard Deviation 16.07
|
1.0 Scores on Scale
Standard Deviation 11.17
|
6.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C38D1
|
3.6 Scores on Scale
Standard Deviation 21.88
|
-2.2 Scores on Scale
Standard Deviation 8.07
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C42D1
|
12.5 Scores on Scale
Standard Deviation 16.50
|
0 Scores on Scale
Standard Deviation 9.43
|
13.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C46D1
|
9.3 Scores on Scale
Standard Deviation 14.61
|
3.3 Scores on Scale
Standard Deviation 4.71
|
13.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C50D1
|
9.3 Scores on Scale
Standard Deviation 17.38
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C54D1
|
-1.1 Scores on Scale
Standard Deviation 14.86
|
3.3 Scores on Scale
Standard Deviation 4.71
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C58D1
|
10.0 Scores on Scale
Standard Deviation 23.57
|
13.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C62D1
|
-10.0 Scores on Scale
Standard Deviation 4.71
|
13.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to C66D1
|
—
|
-6.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to EOT (~216 weeks)
|
-13.5 Scores on Scale
Standard Deviation 21.17
|
-14.4 Scores on Scale
Standard Deviation 24.15
|
-14.0 Scores on Scale
Standard Deviation 24.89
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to SFU D30 (~220 weeks)
|
-9.1 Scores on Scale
Standard Deviation 19.62
|
-8.2 Scores on Scale
Standard Deviation 17.87
|
-6.7 Scores on Scale
Standard Deviation 23.09
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
PF, CFB to SFU D90 (~229 weeks)
|
-5.2 Scores on Scale
Standard Deviation 24.42
|
-15.9 Scores on Scale
Standard Deviation 22.72
|
-1.7 Scores on Scale
Standard Deviation 10.75
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C2D1
|
-0.3 Scores on Scale
Standard Deviation 25.09
|
-6.3 Scores on Scale
Standard Deviation 22.77
|
-4.6 Scores on Scale
Standard Deviation 23.28
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C3D1
|
0 Scores on Scale
Standard Deviation 26.98
|
-4.0 Scores on Scale
Standard Deviation 28.22
|
-5.9 Scores on Scale
Standard Deviation 28.58
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C4D1
|
-4.8 Scores on Scale
Standard Deviation 26.55
|
-7.4 Scores on Scale
Standard Deviation 25.40
|
-7.4 Scores on Scale
Standard Deviation 25.90
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C5D1
|
-5.2 Scores on Scale
Standard Deviation 28.81
|
-7.4 Scores on Scale
Standard Deviation 26.83
|
-3.5 Scores on Scale
Standard Deviation 23.72
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C6D1
|
-2.9 Scores on Scale
Standard Deviation 28.62
|
-5.8 Scores on Scale
Standard Deviation 24.98
|
-6.7 Scores on Scale
Standard Deviation 22.69
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C9D1
|
-3.1 Scores on Scale
Standard Deviation 29.22
|
-7.1 Scores on Scale
Standard Deviation 26.77
|
-5.2 Scores on Scale
Standard Deviation 21.41
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C12D1
|
-2.2 Scores on Scale
Standard Deviation 31.40
|
-5.9 Scores on Scale
Standard Deviation 23.52
|
-11.8 Scores on Scale
Standard Deviation 29.32
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C15D1
|
-3.2 Scores on Scale
Standard Deviation 25.64
|
-7.3 Scores on Scale
Standard Deviation 23.82
|
-12.5 Scores on Scale
Standard Deviation 24.80
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C18D1
|
-0.4 Scores on Scale
Standard Deviation 23.14
|
-7.8 Scores on Scale
Standard Deviation 19.93
|
-4.2 Scores on Scale
Standard Deviation 8.33
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C22D1
|
-5.3 Scores on Scale
Standard Deviation 28.73
|
-6.8 Scores on Scale
Standard Deviation 24.48
|
-8.3 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C26D1
|
-1.0 Scores on Scale
Standard Deviation 32.29
|
-8.8 Scores on Scale
Standard Deviation 19.65
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C30D1
|
0.6 Scores on Scale
Standard Deviation 28.86
|
-15.5 Scores on Scale
Standard Deviation 26.53
|
-16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C34D1
|
4.4 Scores on Scale
Standard Deviation 20.67
|
-2.4 Scores on Scale
Standard Deviation 17.82
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C38D1
|
-1.3 Scores on Scale
Standard Deviation 30.02
|
-2.8 Scores on Scale
Standard Deviation 35.62
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C42D1
|
8.3 Scores on Scale
Standard Deviation 25.20
|
-12.5 Scores on Scale
Standard Deviation 25.00
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C46D1
|
6.7 Scores on Scale
Standard Deviation 19.00
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C50D1
|
13.3 Scores on Scale
Standard Deviation 18.26
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C54D1
|
5.6 Scores on Scale
Standard Deviation 20.18
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to C66D1
|
—
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to EOT (~216 weeks)
|
-16.3 Scores on Scale
Standard Deviation 31.44
|
-17.9 Scores on Scale
Standard Deviation 28.81
|
-14.7 Scores on Scale
Standard Deviation 29.23
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to SFU D30 (~220 weeks)
|
-7.7 Scores on Scale
Standard Deviation 34.80
|
-13.7 Scores on Scale
Standard Deviation 15.71
|
-14.6 Scores on Scale
Standard Deviation 25.21
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
RF, CFB to SFU D90(~229 weeks)
|
-2.4 Scores on Scale
Standard Deviation 37.47
|
-18.8 Scores on Scale
Standard Deviation 27.20
|
-11.5 Scores on Scale
Standard Deviation 24.88
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C2D1
|
3.7 Scores on Scale
Standard Deviation 18.64
|
2.5 Scores on Scale
Standard Deviation 17.74
|
-0.9 Scores on Scale
Standard Deviation 17.35
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C3D1
|
3.9 Scores on Scale
Standard Deviation 17.82
|
1.5 Scores on Scale
Standard Deviation 19.48
|
-2.3 Scores on Scale
Standard Deviation 18.11
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C4D1
|
3.6 Scores on Scale
Standard Deviation 20.25
|
-0.7 Scores on Scale
Standard Deviation 19.13
|
-0.3 Scores on Scale
Standard Deviation 20.43
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C5D1
|
3.5 Scores on Scale
Standard Deviation 20.33
|
-0.3 Scores on Scale
Standard Deviation 20.70
|
1.6 Scores on Scale
Standard Deviation 19.06
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C6D1
|
3.6 Scores on Scale
Standard Deviation 20.67
|
2.2 Scores on Scale
Standard Deviation 21.96
|
1.9 Scores on Scale
Standard Deviation 17.43
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C9D1
|
3.7 Scores on Scale
Standard Deviation 20.46
|
-1.6 Scores on Scale
Standard Deviation 19.86
|
-5.5 Scores on Scale
Standard Deviation 20.32
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C12D1
|
0.1 Scores on Scale
Standard Deviation 20.39
|
1.0 Scores on Scale
Standard Deviation 16.53
|
-3.4 Scores on Scale
Standard Deviation 23.76
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C15D1
|
1.4 Scores on Scale
Standard Deviation 22.03
|
2.1 Scores on Scale
Standard Deviation 20.83
|
-3.1 Scores on Scale
Standard Deviation 19.38
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C18D1
|
1.7 Scores on Scale
Standard Deviation 20.13
|
0.6 Scores on Scale
Standard Deviation 16.66
|
-6.3 Scores on Scale
Standard Deviation 12.50
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C22D1
|
-0.4 Scores on Scale
Standard Deviation 19.72
|
0.8 Scores on Scale
Standard Deviation 18.17
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C26D1
|
1.2 Scores on Scale
Standard Deviation 15.91
|
0.5 Scores on Scale
Standard Deviation 18.97
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C30D1
|
3.2 Scores on Scale
Standard Deviation 18.57
|
-1.8 Scores on Scale
Standard Deviation 11.41
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C34D1
|
5.7 Scores on Scale
Standard Deviation 19.26
|
-7.1 Scores on Scale
Standard Deviation 20.65
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C38D1
|
-0.6 Scores on Scale
Standard Deviation 16.12
|
-2.8 Scores on Scale
Standard Deviation 22.77
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C42D1
|
6.3 Scores on Scale
Standard Deviation 8.63
|
0 Scores on Scale
Standard Deviation 11.79
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C46D1
|
1.7 Scores on Scale
Standard Deviation 10.87
|
12.5 Scores on Scale
Standard Deviation 17.68
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C50D1
|
5.0 Scores on Scale
Standard Deviation 19.18
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C54D1
|
15.3 Scores on Scale
Standard Deviation 24.39
|
8.3 Scores on Scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C62D1
|
37.5 Scores on Scale
Standard Deviation 41.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to C66D1
|
—
|
-16.7 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to EOT (~216 weeks)
|
-5.3 Scores on Scale
Standard Deviation 22.15
|
-7.4 Scores on Scale
Standard Deviation 21.20
|
-7.7 Scores on Scale
Standard Deviation 26.44
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to SFU D30(~220 weeks)
|
-2.6 Scores on Scale
Standard Deviation 17.54
|
-3.4 Scores on Scale
Standard Deviation 14.90
|
-2.1 Scores on Scale
Standard Deviation 21.74
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
EF, CFB to SFU D90(~229 weeks)
|
-6.0 Scores on Scale
Standard Deviation 22.03
|
-8.3 Scores on Scale
Standard Deviation 18.12
|
1.6 Scores on Scale
Standard Deviation 16.45
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C2D1
|
0.3 Scores on Scale
Standard Deviation 16.00
|
-0.8 Scores on Scale
Standard Deviation 18.02
|
-2.1 Scores on Scale
Standard Deviation 14.74
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C3D1
|
0 Scores on Scale
Standard Deviation 14.23
|
-1.4 Scores on Scale
Standard Deviation 16.33
|
-3.9 Scores on Scale
Standard Deviation 18.03
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C4D1
|
0.1 Scores on Scale
Standard Deviation 16.84
|
-2.0 Scores on Scale
Standard Deviation 18.05
|
0.2 Scores on Scale
Standard Deviation 12.49
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C5D1
|
0.1 Scores on Scale
Standard Deviation 19.32
|
-3.1 Scores on Scale
Standard Deviation 16.96
|
-0.6 Scores on Scale
Standard Deviation 17.81
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C6D1
|
1.6 Scores on Scale
Standard Deviation 16.42
|
-2.8 Scores on Scale
Standard Deviation 18.35
|
-0.6 Scores on Scale
Standard Deviation 17.14
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C9D1
|
2.1 Scores on Scale
Standard Deviation 16.94
|
-5.9 Scores on Scale
Standard Deviation 19.19
|
-2.3 Scores on Scale
Standard Deviation 20.28
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C12D1
|
0.9 Scores on Scale
Standard Deviation 19.16
|
-4.3 Scores on Scale
Standard Deviation 19.39
|
-2.0 Scores on Scale
Standard Deviation 11.61
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C15D1
|
1.7 Scores on Scale
Standard Deviation 13.50
|
-4.3 Scores on Scale
Standard Deviation 22.85
|
-4.2 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C18D1
|
1.6 Scores on Scale
Standard Deviation 15.78
|
-1.7 Scores on Scale
Standard Deviation 19.74
|
-4.2 Scores on Scale
Standard Deviation 8.33
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C22D1
|
3.7 Scores on Scale
Standard Deviation 16.03
|
-4.5 Scores on Scale
Standard Deviation 17.95
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C26D1
|
2.0 Scores on Scale
Standard Deviation 15.22
|
-2.9 Scores on Scale
Standard Deviation 19.75
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C30D1
|
-1.3 Scores on Scale
Standard Deviation 17.59
|
-9.5 Scores on Scale
Standard Deviation 22.37
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C34D1
|
1.8 Scores on Scale
Standard Deviation 14.59
|
-7.1 Scores on Scale
Standard Deviation 16.27
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C38D1
|
-2.6 Scores on Scale
Standard Deviation 20.24
|
-2.8 Scores on Scale
Standard Deviation 19.48
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C42D1
|
2.1 Scores on Scale
Standard Deviation 13.91
|
-16.7 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C46D1
|
3.3 Scores on Scale
Standard Deviation 13.94
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C50D1
|
-6.7 Scores on Scale
Standard Deviation 19.00
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C54D1
|
2.8 Scores on Scale
Standard Deviation 12.55
|
0 Scores on Scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C58D1
|
16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to C66D1
|
—
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to EOT (~216 weeks)
|
-6.2 Scores on Scale
Standard Deviation 21.47
|
-8.0 Scores on Scale
Standard Deviation 20.26
|
-7.7 Scores on Scale
Standard Deviation 21.97
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to SFU D30(~220 weeks)
|
-2.6 Scores on Scale
Standard Deviation 24.34
|
-6.0 Scores on Scale
Standard Deviation 17.31
|
-2.8 Scores on Scale
Standard Deviation 22.34
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
CF, CFB to SFU D90(~229 weeks)
|
-6.0 Scores on Scale
Standard Deviation 33.08
|
-8.7 Scores on Scale
Standard Deviation 22.96
|
1.0 Scores on Scale
Standard Deviation 17.71
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C2D1
|
-0.3 Scores on Scale
Standard Deviation 23.31
|
0.4 Scores on Scale
Standard Deviation 24.37
|
-4.9 Scores on Scale
Standard Deviation 22.16
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C3D1
|
-0.4 Scores on Scale
Standard Deviation 23.30
|
0.7 Scores on Scale
Standard Deviation 24.87
|
-6.7 Scores on Scale
Standard Deviation 22.58
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C4D1
|
-2.8 Scores on Scale
Standard Deviation 23.01
|
-3.7 Scores on Scale
Standard Deviation 25.81
|
-4.7 Scores on Scale
Standard Deviation 23.17
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C5D1
|
-3.6 Scores on Scale
Standard Deviation 24.75
|
-2.2 Scores on Scale
Standard Deviation 25.39
|
-4.7 Scores on Scale
Standard Deviation 24.35
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C6D1
|
-1.6 Scores on Scale
Standard Deviation 24.23
|
-0.4 Scores on Scale
Standard Deviation 23.51
|
-3.5 Scores on Scale
Standard Deviation 20.96
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C9D1
|
1.5 Scores on Scale
Standard Deviation 22.74
|
-7.3 Scores on Scale
Standard Deviation 28.22
|
-10.9 Scores on Scale
Standard Deviation 20.55
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C12D1
|
-2.0 Scores on Scale
Standard Deviation 24.35
|
-3.4 Scores on Scale
Standard Deviation 24.53
|
-3.9 Scores on Scale
Standard Deviation 20.01
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C15D1
|
0.9 Scores on Scale
Standard Deviation 22.82
|
0.4 Scores on Scale
Standard Deviation 18.13
|
-10.4 Scores on Scale
Standard Deviation 25.10
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C18D1
|
-0.4 Scores on Scale
Standard Deviation 18.72
|
-3.9 Scores on Scale
Standard Deviation 22.61
|
4.2 Scores on Scale
Standard Deviation 8.33
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C22D1
|
-2.0 Scores on Scale
Standard Deviation 20.14
|
-0.8 Scores on Scale
Standard Deviation 21.50
|
8.3 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C26D1
|
-7.8 Scores on Scale
Standard Deviation 21.41
|
-8.8 Scores on Scale
Standard Deviation 22.14
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C30D1
|
-0.6 Scores on Scale
Standard Deviation 20.27
|
-9.5 Scores on Scale
Standard Deviation 21.40
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C34D1
|
-1.8 Scores on Scale
Standard Deviation 19.95
|
-7.1 Scores on Scale
Standard Deviation 21.21
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C38D1
|
-1.3 Scores on Scale
Standard Deviation 28.43
|
-13.9 Scores on Scale
Standard Deviation 19.48
|
—
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
SF, CFB to C42D1
|
4.2 Scores on Scale
Standard Deviation 23.15
|
-4.2 Scores on Scale
Standard Deviation 43.83
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
SECONDARY outcome
Timeframe: Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)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 categories. Rows and Arms/Groups with 0 participants analyzed represent time points at which no participant data was available from within the respective Arms/Groups.
The QLQ-LC13 questionnaire comprises 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain which includes pain in chest, pain in arm or shoulder and pain in other parts), and treatment-related side effects (sore mouth \[SM\], dysphagia, peripheral neuropathy \[PN\] and alopecia). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100. Higher scores represent increasing symptom levels. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=305 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=301 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=152 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C42D1
|
0 Scores on Scale
Standard Deviation 0
|
-8.3 Scores on Scale
Standard Deviation 16.67
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C3D1
|
3.5 Scores on Scale
Standard Deviation 20.81
|
2.9 Scores on Scale
Standard Deviation 18.54
|
2.3 Scores on Scale
Standard Deviation 15.79
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C2D1
|
1.9 Scores on Scale
Standard Deviation 17.41
|
0.8 Scores on Scale
Standard Deviation 17.57
|
4.2 Scores on Scale
Standard Deviation 17.80
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C4D1
|
3.1 Scores on Scale
Standard Deviation 19.80
|
3.4 Scores on Scale
Standard Deviation 18.11
|
5.8 Scores on Scale
Standard Deviation 19.05
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C5D1
|
5.8 Scores on Scale
Standard Deviation 21.53
|
5.0 Scores on Scale
Standard Deviation 17.79
|
6.7 Scores on Scale
Standard Deviation 22.99
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C6D1
|
5.4 Scores on Scale
Standard Deviation 21.22
|
4.6 Scores on Scale
Standard Deviation 17.63
|
4.3 Scores on Scale
Standard Deviation 16.01
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C9D1
|
6.2 Scores on Scale
Standard Deviation 22.90
|
6.7 Scores on Scale
Standard Deviation 17.00
|
9.1 Scores on Scale
Standard Deviation 22.03
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C12D1
|
6.1 Scores on Scale
Standard Deviation 21.31
|
3.8 Scores on Scale
Standard Deviation 17.48
|
17.6 Scores on Scale
Standard Deviation 24.55
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C15D1
|
7.3 Scores on Scale
Standard Deviation 17.92
|
-2.0 Scores on Scale
Standard Deviation 17.08
|
23.6 Scores on Scale
Standard Deviation 34.34
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C18D1
|
5.0 Scores on Scale
Standard Deviation 14.00
|
-1.5 Scores on Scale
Standard Deviation 16.18
|
22.2 Scores on Scale
Standard Deviation 18.14
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C22D1
|
6.5 Scores on Scale
Standard Deviation 17.21
|
-5.1 Scores on Scale
Standard Deviation 20.21
|
11.1 Scores on Scale
Standard Deviation 15.71
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C26D1
|
8.7 Scores on Scale
Standard Deviation 15.65
|
-2.0 Scores on Scale
Standard Deviation 21.24
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C30D1
|
6.7 Scores on Scale
Standard Deviation 15.71
|
-0.8 Scores on Scale
Standard Deviation 16.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C34D1
|
8.3 Scores on Scale
Standard Deviation 20.35
|
4.8 Scores on Scale
Standard Deviation 14.14
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C38D1
|
6.0 Scores on Scale
Standard Deviation 20.09
|
3.7 Scores on Scale
Standard Deviation 11.48
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C42D1
|
2.8 Scores on Scale
Standard Deviation 11.50
|
8.3 Scores on Scale
Standard Deviation 18.98
|
22.2 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C46D1
|
0 Scores on Scale
Standard Deviation 15.71
|
-5.6 Scores on Scale
Standard Deviation 7.86
|
22.2 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C50D1
|
3.7 Scores on Scale
Standard Deviation 5.74
|
-11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C54D1
|
-1.9 Scores on Scale
Standard Deviation 20.39
|
-5.6 Scores on Scale
Standard Deviation 7.86
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C58D1
|
7.4 Scores on Scale
Standard Deviation 6.42
|
-11.1 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C62D1
|
-5.6 Scores on Scale
Standard Deviation 7.86
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to EOT (~216 weeks)
|
14.3 Scores on Scale
Standard Deviation 24.13
|
14.3 Scores on Scale
Standard Deviation 26.58
|
9.7 Scores on Scale
Standard Deviation 22.35
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to SFU D30 (~220 weeks)
|
16.5 Scores on Scale
Standard Deviation 21.95
|
13.9 Scores on Scale
Standard Deviation 23.97
|
8.2 Scores on Scale
Standard Deviation 23.98
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dyspnea, CFB to SFU D90 (~229 weeks)
|
9.5 Scores on Scale
Standard Deviation 17.35
|
25.1 Scores on Scale
Standard Deviation 21.25
|
4.2 Scores on Scale
Standard Deviation 26.87
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C2D1
|
-2.2 Scores on Scale
Standard Deviation 23.06
|
-1.7 Scores on Scale
Standard Deviation 24.73
|
-0.3 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C3D1
|
-2.2 Scores on Scale
Standard Deviation 24.66
|
-2.1 Scores on Scale
Standard Deviation 26.13
|
-3.6 Scores on Scale
Standard Deviation 25.88
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C4D1
|
0.6 Scores on Scale
Standard Deviation 26.76
|
-0.9 Scores on Scale
Standard Deviation 29.66
|
-4.0 Scores on Scale
Standard Deviation 26.92
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C5D1
|
-2.5 Scores on Scale
Standard Deviation 26.87
|
-2.1 Scores on Scale
Standard Deviation 27.67
|
-4.3 Scores on Scale
Standard Deviation 26.73
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C6D1
|
0.2 Scores on Scale
Standard Deviation 27.76
|
-4.8 Scores on Scale
Standard Deviation 25.36
|
-4.0 Scores on Scale
Standard Deviation 29.84
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C9D1
|
-0.7 Scores on Scale
Standard Deviation 23.30
|
-2.1 Scores on Scale
Standard Deviation 29.97
|
-1.1 Scores on Scale
Standard Deviation 28.84
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C12D1
|
-2.3 Scores on Scale
Standard Deviation 25.40
|
-7.5 Scores on Scale
Standard Deviation 32.47
|
15.7 Scores on Scale
Standard Deviation 37.49
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C15D1
|
0.6 Scores on Scale
Standard Deviation 17.56
|
-6.0 Scores on Scale
Standard Deviation 28.48
|
16.7 Scores on Scale
Standard Deviation 30.86
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C18D1
|
0.8 Scores on Scale
Standard Deviation 21.99
|
-13.3 Scores on Scale
Standard Deviation 29.81
|
-8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C22D1
|
0.8 Scores on Scale
Standard Deviation 26.34
|
-16.7 Scores on Scale
Standard Deviation 19.92
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C26D1
|
-1.0 Scores on Scale
Standard Deviation 26.07
|
-7.8 Scores on Scale
Standard Deviation 25.08
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C30D1
|
-6.7 Scores on Scale
Standard Deviation 27.22
|
-9.5 Scores on Scale
Standard Deviation 20.37
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C34D1
|
-1.7 Scores on Scale
Standard Deviation 20.16
|
-4.8 Scores on Scale
Standard Deviation 23.00
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C38D1
|
-7.7 Scores on Scale
Standard Deviation 27.74
|
-5.6 Scores on Scale
Standard Deviation 32.77
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C42D1
|
-20.8 Scores on Scale
Standard Deviation 24.80
|
16.7 Scores on Scale
Standard Deviation 33.33
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C46D1
|
-27.8 Scores on Scale
Standard Deviation 38.97
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C50D1
|
-16.7 Scores on Scale
Standard Deviation 45.95
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C54D1
|
-33.3 Scores on Scale
Standard Deviation 36.51
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C58D1
|
-22.2 Scores on Scale
Standard Deviation 19.25
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C62D1
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to EOT(~216 weeks)
|
2.4 Scores on Scale
Standard Deviation 28.55
|
2.8 Scores on Scale
Standard Deviation 32.18
|
2.1 Scores on Scale
Standard Deviation 28.79
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to SFU D30 (~220 weeks)
|
2.9 Scores on Scale
Standard Deviation 33.70
|
3.3 Scores on Scale
Standard Deviation 32.73
|
-1.4 Scores on Scale
Standard Deviation 23.52
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Cough, CFB to SFU D90(~229 weeks)
|
-4.8 Scores on Scale
Standard Deviation 22.10
|
7.2 Scores on Scale
Standard Deviation 31.71
|
0 Scores on Scale
Standard Deviation 21.08
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C2D1
|
-0.7 Scores on Scale
Standard Deviation 10.93
|
-2.5 Scores on Scale
Standard Deviation 11.08
|
0.3 Scores on Scale
Standard Deviation 10.10
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C3D1
|
-1.3 Scores on Scale
Standard Deviation 10.64
|
-1.3 Scores on Scale
Standard Deviation 12.08
|
0.4 Scores on Scale
Standard Deviation 14.16
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C4D1
|
-1.4 Scores on Scale
Standard Deviation 13.82
|
-1.9 Scores on Scale
Standard Deviation 10.87
|
0 Scores on Scale
Standard Deviation 12.97
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C5D1
|
-2.0 Scores on Scale
Standard Deviation 13.60
|
-1.3 Scores on Scale
Standard Deviation 11.38
|
0 Scores on Scale
Standard Deviation 12.95
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C6D1
|
-1.9 Scores on Scale
Standard Deviation 15.00
|
-1.8 Scores on Scale
Standard Deviation 8.81
|
-0.7 Scores on Scale
Standard Deviation 10.63
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C9D1
|
-2.6 Scores on Scale
Standard Deviation 13.43
|
-0.8 Scores on Scale
Standard Deviation 10.51
|
0 Scores on Scale
Standard Deviation 8.91
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C12D1
|
-1.4 Scores on Scale
Standard Deviation 16.37
|
-1.7 Scores on Scale
Standard Deviation 11.55
|
2.0 Scores on Scale
Standard Deviation 8.08
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C15D1
|
-0.6 Scores on Scale
Standard Deviation 10.12
|
1.7 Scores on Scale
Standard Deviation 10.68
|
0 Scores on Scale
Standard Deviation 17.82
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C18D1
|
0 Scores on Scale
Standard Deviation 7.55
|
-2.2 Scores on Scale
Standard Deviation 8.46
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C22D1
|
3.3 Scores on Scale
Standard Deviation 14.54
|
-3.0 Scores on Scale
Standard Deviation 9.81
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C26D1
|
-2.1 Scores on Scale
Standard Deviation 8.20
|
-2.0 Scores on Scale
Standard Deviation 14.29
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C30D1
|
-1.3 Scores on Scale
Standard Deviation 6.67
|
-4.8 Scores on Scale
Standard Deviation 12.10
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C34D1
|
0 Scores on Scale
Standard Deviation 0
|
-4.8 Scores on Scale
Standard Deviation 12.60
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C38D1
|
-2.6 Scores on Scale
Standard Deviation 9.25
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C46D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C50D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C54D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Haemoptysis, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to EOT(~216 weeks)
|
2.7 Scores on Scale
Standard Deviation 12.76
|
1.3 Scores on Scale
Standard Deviation 15.08
|
1.0 Scores on Scale
Standard Deviation 11.74
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to SFU D30
|
-1.0 Scores on Scale
Standard Deviation 12.75
|
2.5 Scores on Scale
Standard Deviation 8.89
|
-1.4 Scores on Scale
Standard Deviation 6.95
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Hemoptysis, CFB to SFU D90(~229 weeks)
|
0 Scores on Scale
Standard Deviation 13.07
|
2.9 Scores on Scale
Standard Deviation 13.90
|
2.1 Scores on Scale
Standard Deviation 8.33
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C2D1
|
5.6 Scores on Scale
Standard Deviation 21.37
|
5.2 Scores on Scale
Standard Deviation 24.18
|
3.0 Scores on Scale
Standard Deviation 19.69
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C3D1
|
7.7 Scores on Scale
Standard Deviation 22.06
|
7.5 Scores on Scale
Standard Deviation 26.12
|
3.2 Scores on Scale
Standard Deviation 19.78
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C4D1
|
5.3 Scores on Scale
Standard Deviation 18.97
|
6.0 Scores on Scale
Standard Deviation 21.25
|
2.5 Scores on Scale
Standard Deviation 21.17
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C5D1
|
6.0 Scores on Scale
Standard Deviation 19.40
|
6.3 Scores on Scale
Standard Deviation 24.66
|
3.1 Scores on Scale
Standard Deviation 20.75
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C6D1
|
5.3 Scores on Scale
Standard Deviation 18.12
|
2.7 Scores on Scale
Standard Deviation 17.49
|
2.7 Scores on Scale
Standard Deviation 21.12
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C9D1
|
4.0 Scores on Scale
Standard Deviation 18.48
|
2.5 Scores on Scale
Standard Deviation 18.84
|
6.9 Scores on Scale
Standard Deviation 22.50
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C12D1
|
0.5 Scores on Scale
Standard Deviation 13.21
|
2.3 Scores on Scale
Standard Deviation 22.39
|
2.0 Scores on Scale
Standard Deviation 18.52
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C15D1
|
2.4 Scores on Scale
Standard Deviation 15.52
|
-1.7 Scores on Scale
Standard Deviation 18.65
|
12.5 Scores on Scale
Standard Deviation 35.36
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C18D1
|
-0.8 Scores on Scale
Standard Deviation 9.21
|
-1.1 Scores on Scale
Standard Deviation 16.34
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C22D1
|
0 Scores on Scale
Standard Deviation 7.45
|
3.0 Scores on Scale
Standard Deviation 14.21
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C26D1
|
2.1 Scores on Scale
Standard Deviation 14.51
|
2.0 Scores on Scale
Standard Deviation 14.29
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C30D1
|
2.7 Scores on Scale
Standard Deviation 13.33
|
2.4 Scores on Scale
Standard Deviation 8.91
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C34D1
|
1.7 Scores on Scale
Standard Deviation 13.13
|
4.8 Scores on Scale
Standard Deviation 12.60
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C38D1
|
2.6 Scores on Scale
Standard Deviation 9.25
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C42D1
|
0 Scores on Scale
Standard Deviation 0
|
16.7 Scores on Scale
Standard Deviation 19.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C46D1
|
5.6 Scores on Scale
Standard Deviation 13.61
|
16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C54D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to C66D1
|
—
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to EOT(~216 weeks)
|
3.3 Scores on Scale
Standard Deviation 15.47
|
8.3 Scores on Scale
Standard Deviation 25.18
|
1.0 Scores on Scale
Standard Deviation 17.65
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to SFU D30 (~220 weeks)
|
2.9 Scores on Scale
Standard Deviation 21.95
|
1.7 Scores on Scale
Standard Deviation 15.00
|
1.4 Scores on Scale
Standard Deviation 15.82
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
SM, CFB to SFU D90 (~229 weeks)
|
2.4 Scores on Scale
Standard Deviation 8.91
|
1.4 Scores on Scale
Standard Deviation 21.27
|
8.3 Scores on Scale
Standard Deviation 19.25
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C2D1
|
1.0 Scores on Scale
Standard Deviation 17.62
|
2.2 Scores on Scale
Standard Deviation 15.34
|
2.0 Scores on Scale
Standard Deviation 18.94
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C3D1
|
0.7 Scores on Scale
Standard Deviation 18.33
|
4.0 Scores on Scale
Standard Deviation 16.17
|
5.6 Scores on Scale
Standard Deviation 23.04
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C4D1
|
0 Scores on Scale
Standard Deviation 17.01
|
1.9 Scores on Scale
Standard Deviation 16.17
|
4.5 Scores on Scale
Standard Deviation 20.84
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C5D1
|
2.0 Scores on Scale
Standard Deviation 16.14
|
2.1 Scores on Scale
Standard Deviation 19.95
|
3.1 Scores on Scale
Standard Deviation 16.21
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C6D1
|
0.7 Scores on Scale
Standard Deviation 15.84
|
0.3 Scores on Scale
Standard Deviation 14.56
|
2.7 Scores on Scale
Standard Deviation 17.61
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C9D1
|
1.5 Scores on Scale
Standard Deviation 16.41
|
1.6 Scores on Scale
Standard Deviation 13.85
|
1.1 Scores on Scale
Standard Deviation 14.04
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C12D1
|
-2.8 Scores on Scale
Standard Deviation 13.51
|
5.2 Scores on Scale
Standard Deviation 21.45
|
3.9 Scores on Scale
Standard Deviation 11.07
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C15D1
|
-1.2 Scores on Scale
Standard Deviation 12.77
|
-0.9 Scores on Scale
Standard Deviation 5.34
|
4.2 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C18D1
|
0.8 Scores on Scale
Standard Deviation 11.91
|
0 Scores on Scale
Standard Deviation 8.75
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C22D1
|
-1.6 Scores on Scale
Standard Deviation 12.80
|
-3.0 Scores on Scale
Standard Deviation 9.81
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C26D1
|
-1.0 Scores on Scale
Standard Deviation 13.35
|
0 Scores on Scale
Standard Deviation 11.79
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C30D1
|
-1.3 Scores on Scale
Standard Deviation 11.71
|
2.4 Scores on Scale
Standard Deviation 8.91
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C34D1
|
-1.7 Scores on Scale
Standard Deviation 7.45
|
14.3 Scores on Scale
Standard Deviation 26.23
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C38D1
|
-2.6 Scores on Scale
Standard Deviation 9.25
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C42D1
|
4.2 Scores on Scale
Standard Deviation 11.79
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C46D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C54D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C58D1
|
-11.1 Scores on Scale
Standard Deviation 19.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C62D1
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to C66D1
|
—
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to EOT(~216 weeks)
|
5.4 Scores on Scale
Standard Deviation 19.79
|
8.3 Scores on Scale
Standard Deviation 20.33
|
5.6 Scores on Scale
Standard Deviation 18.23
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to SFU D30 (~220 weeks)
|
1.9 Scores on Scale
Standard Deviation 22.78
|
0.8 Scores on Scale
Standard Deviation 14.10
|
2.9 Scores on Scale
Standard Deviation 24.44
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Dysphagia, CFB to SFU D90 (~229 weeks)
|
7.1 Scores on Scale
Standard Deviation 14.19
|
8.7 Scores on Scale
Standard Deviation 20.64
|
4.2 Scores on Scale
Standard Deviation 11.39
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C2D1
|
2.7 Scores on Scale
Standard Deviation 19.38
|
-1.0 Scores on Scale
Standard Deviation 22.14
|
2.7 Scores on Scale
Standard Deviation 21.12
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C3D1
|
3.4 Scores on Scale
Standard Deviation 24.46
|
1.0 Scores on Scale
Standard Deviation 25.01
|
4.8 Scores on Scale
Standard Deviation 22.64
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C4D1
|
5.3 Scores on Scale
Standard Deviation 23.94
|
3.4 Scores on Scale
Standard Deviation 26.01
|
8.5 Scores on Scale
Standard Deviation 22.73
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C5D1
|
10.6 Scores on Scale
Standard Deviation 29.11
|
9.1 Scores on Scale
Standard Deviation 27.97
|
1.2 Scores on Scale
Standard Deviation 20.44
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C6D1
|
10.0 Scores on Scale
Standard Deviation 24.71
|
6.9 Scores on Scale
Standard Deviation 29.17
|
6.0 Scores on Scale
Standard Deviation 25.81
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C9D1
|
9.3 Scores on Scale
Standard Deviation 27.83
|
12.8 Scores on Scale
Standard Deviation 29.61
|
9.5 Scores on Scale
Standard Deviation 23.76
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C12D1
|
11.9 Scores on Scale
Standard Deviation 26.64
|
5.7 Scores on Scale
Standard Deviation 21.75
|
9.8 Scores on Scale
Standard Deviation 15.66
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C15D1
|
7.9 Scores on Scale
Standard Deviation 27.19
|
7.7 Scores on Scale
Standard Deviation 30.07
|
4.2 Scores on Scale
Standard Deviation 21.36
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C18D1
|
14.2 Scores on Scale
Standard Deviation 30.09
|
5.6 Scores on Scale
Standard Deviation 30.43
|
16.7 Scores on Scale
Standard Deviation 19.25
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C22D1
|
6.5 Scores on Scale
Standard Deviation 23.83
|
9.1 Scores on Scale
Standard Deviation 27.57
|
16.7 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C26D1
|
1.0 Scores on Scale
Standard Deviation 29.92
|
3.9 Scores on Scale
Standard Deviation 30.92
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C30D1
|
10.7 Scores on Scale
Standard Deviation 24.94
|
0 Scores on Scale
Standard Deviation 18.49
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C34D1
|
-5.0 Scores on Scale
Standard Deviation 27.09
|
14.3 Scores on Scale
Standard Deviation 17.82
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C38D1
|
0 Scores on Scale
Standard Deviation 33.33
|
0 Scores on Scale
Standard Deviation 21.08
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C42D1
|
-4.2 Scores on Scale
Standard Deviation 21.36
|
16.7 Scores on Scale
Standard Deviation 19.25
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C46D1
|
-5.6 Scores on Scale
Standard Deviation 25.09
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C50D1
|
5.6 Scores on Scale
Standard Deviation 25.09
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C54D1
|
-11.1 Scores on Scale
Standard Deviation 40.37
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C58D1
|
-22.2 Scores on Scale
Standard Deviation 50.92
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C62D1
|
-50.0 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to EOT(~216 weeks)
|
11.4 Scores on Scale
Standard Deviation 27.52
|
11.1 Scores on Scale
Standard Deviation 28.44
|
8.3 Scores on Scale
Standard Deviation 28.48
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to SFU D30 (~220 weeks)
|
6.7 Scores on Scale
Standard Deviation 25.31
|
11.7 Scores on Scale
Standard Deviation 24.52
|
13.0 Scores on Scale
Standard Deviation 24.08
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
PN, CFB to SFU D90 (~229 weeks)
|
14.3 Scores on Scale
Standard Deviation 38.60
|
10.1 Scores on Scale
Standard Deviation 25.49
|
6.3 Scores on Scale
Standard Deviation 27.81
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C2D1
|
41.3 Scores on Scale
Standard Deviation 40.53
|
42.5 Scores on Scale
Standard Deviation 43.95
|
42.4 Scores on Scale
Standard Deviation 42.54
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C3D1
|
41.4 Scores on Scale
Standard Deviation 36.95
|
40.6 Scores on Scale
Standard Deviation 40.05
|
38.9 Scores on Scale
Standard Deviation 43.24
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C4D1
|
34.5 Scores on Scale
Standard Deviation 35.69
|
36.8 Scores on Scale
Standard Deviation 41.51
|
35.8 Scores on Scale
Standard Deviation 40.75
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C5D1
|
37.8 Scores on Scale
Standard Deviation 35.23
|
36.7 Scores on Scale
Standard Deviation 37.38
|
34.0 Scores on Scale
Standard Deviation 39.65
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C6D1
|
38.9 Scores on Scale
Standard Deviation 35.93
|
37.2 Scores on Scale
Standard Deviation 40.14
|
36.7 Scores on Scale
Standard Deviation 38.83
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C9D1
|
23.8 Scores on Scale
Standard Deviation 37.61
|
30.0 Scores on Scale
Standard Deviation 44.60
|
40.2 Scores on Scale
Standard Deviation 43.08
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C12D1
|
19.2 Scores on Scale
Standard Deviation 35.93
|
20.1 Scores on Scale
Standard Deviation 37.95
|
41.2 Scores on Scale
Standard Deviation 41.72
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C15D1
|
9.7 Scores on Scale
Standard Deviation 33.13
|
5.1 Scores on Scale
Standard Deviation 22.35
|
37.5 Scores on Scale
Standard Deviation 45.21
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C18D1
|
0.8 Scores on Scale
Standard Deviation 25.58
|
5.6 Scores on Scale
Standard Deviation 27.80
|
58.3 Scores on Scale
Standard Deviation 50.00
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C22D1
|
7.3 Scores on Scale
Standard Deviation 32.07
|
12.1 Scores on Scale
Standard Deviation 28.26
|
16.7 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C26D1
|
-4.2 Scores on Scale
Standard Deviation 22.00
|
2.0 Scores on Scale
Standard Deviation 21.96
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C30D1
|
-2.7 Scores on Scale
Standard Deviation 21.34
|
2.4 Scores on Scale
Standard Deviation 24.33
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C34D1
|
-1.7 Scores on Scale
Standard Deviation 17.01
|
4.8 Scores on Scale
Standard Deviation 12.60
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C38D1
|
0 Scores on Scale
Standard Deviation 19.25
|
5.6 Scores on Scale
Standard Deviation 25.09
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C42D1
|
-4.2 Scores on Scale
Standard Deviation 11.79
|
-8.3 Scores on Scale
Standard Deviation 16.67
|
100.0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C46D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 21.08
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C54D1
|
5.6 Scores on Scale
Standard Deviation 13.61
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C62D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to EOT (~216 weeks)
|
20.5 Scores on Scale
Standard Deviation 38.55
|
21.7 Scores on Scale
Standard Deviation 41.59
|
23.4 Scores on Scale
Standard Deviation 39.25
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to SFU D30 (~220 weeks)
|
12.4 Scores on Scale
Standard Deviation 33.42
|
7.5 Scores on Scale
Standard Deviation 26.67
|
13.0 Scores on Scale
Standard Deviation 32.94
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Alopecia, CFB to SFU D90 (~229 weeks)
|
9.5 Scores on Scale
Standard Deviation 42.22
|
5.8 Scores on Scale
Standard Deviation 39.76
|
4.2 Scores on Scale
Standard Deviation 26.87
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C2D1
|
-2.3 Scores on Scale
Standard Deviation 22.40
|
0 Scores on Scale
Standard Deviation 21.91
|
2.4 Scores on Scale
Standard Deviation 19.88
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C3D1
|
-2.7 Scores on Scale
Standard Deviation 18.40
|
-1.0 Scores on Scale
Standard Deviation 21.63
|
4.0 Scores on Scale
Standard Deviation 20.43
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C4D1
|
-1.8 Scores on Scale
Standard Deviation 19.33
|
-1.9 Scores on Scale
Standard Deviation 21.16
|
-1.0 Scores on Scale
Standard Deviation 20.23
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C5D1
|
-0.9 Scores on Scale
Standard Deviation 21.63
|
-2.6 Scores on Scale
Standard Deviation 19.45
|
-1.3 Scores on Scale
Standard Deviation 23.54
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C6D1
|
-0.7 Scores on Scale
Standard Deviation 24.07
|
2.4 Scores on Scale
Standard Deviation 19.44
|
0 Scores on Scale
Standard Deviation 22.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C9D1
|
2.6 Scores on Scale
Standard Deviation 20.74
|
2.9 Scores on Scale
Standard Deviation 23.69
|
4.6 Scores on Scale
Standard Deviation 19.36
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C12D1
|
-0.5 Scores on Scale
Standard Deviation 20.06
|
2.9 Scores on Scale
Standard Deviation 25.20
|
11.8 Scores on Scale
Standard Deviation 20.21
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C15D1
|
1.2 Scores on Scale
Standard Deviation 14.29
|
0.9 Scores on Scale
Standard Deviation 17.91
|
4.2 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C18D1
|
-3.3 Scores on Scale
Standard Deviation 18.18
|
1.1 Scores on Scale
Standard Deviation 16.34
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C22D1
|
4.1 Scores on Scale
Standard Deviation 19.99
|
-6.1 Scores on Scale
Standard Deviation 19.62
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C26D1
|
0 Scores on Scale
Standard Deviation 18.93
|
-3.9 Scores on Scale
Standard Deviation 23.22
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C30D1
|
-1.3 Scores on Scale
Standard Deviation 17.95
|
-4.8 Scores on Scale
Standard Deviation 25.68
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C34D1
|
-1.7 Scores on Scale
Standard Deviation 20.16
|
0 Scores on Scale
Standard Deviation 19.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C38D1
|
-5.1 Scores on Scale
Standard Deviation 12.52
|
-5.6 Scores on Scale
Standard Deviation 38.97
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C42D1
|
-4.2 Scores on Scale
Standard Deviation 21.36
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C46D1
|
-5.6 Scores on Scale
Standard Deviation 13.61
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 0
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C54D1
|
-11.1 Scores on Scale
Standard Deviation 17.21
|
0 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C58D1
|
-11.1 Scores on Scale
Standard Deviation 19.25
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C62D1
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to EOT (~216 weeks)
|
7.5 Scores on Scale
Standard Deviation 26.09
|
5.3 Scores on Scale
Standard Deviation 23.60
|
2.1 Scores on Scale
Standard Deviation 24.59
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to SFU D30 (~220 weeks)
|
3.8 Scores on Scale
Standard Deviation 21.04
|
6.7 Scores on Scale
Standard Deviation 21.62
|
12.1 Scores on Scale
Standard Deviation 28.26
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Chest, CFB to SFU D90 (~229 weeks)
|
-7.1 Scores on Scale
Standard Deviation 14.19
|
8.7 Scores on Scale
Standard Deviation 20.64
|
-4.2 Scores on Scale
Standard Deviation 31.91
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C2D1
|
1.0 Scores on Scale
Standard Deviation 22.01
|
-1.7 Scores on Scale
Standard Deviation 21.33
|
-0.3 Scores on Scale
Standard Deviation 20.58
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C3D1
|
-0.4 Scores on Scale
Standard Deviation 22.19
|
-3.1 Scores on Scale
Standard Deviation 24.45
|
0 Scores on Scale
Standard Deviation 22.69
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C4D1
|
-0.8 Scores on Scale
Standard Deviation 22.63
|
0 Scores on Scale
Standard Deviation 23.65
|
0 Scores on Scale
Standard Deviation 20.25
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C5D1
|
2.9 Scores on Scale
Standard Deviation 24.79
|
-1.8 Scores on Scale
Standard Deviation 25.99
|
-0.6 Scores on Scale
Standard Deviation 24.01
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C6D1
|
1.0 Scores on Scale
Standard Deviation 24.48
|
-3.3 Scores on Scale
Standard Deviation 22.45
|
2.0 Scores on Scale
Standard Deviation 23.97
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C9D1
|
5.5 Scores on Scale
Standard Deviation 26.88
|
0.4 Scores on Scale
Standard Deviation 26.08
|
-1.1 Scores on Scale
Standard Deviation 20.86
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C12D1
|
6.6 Scores on Scale
Standard Deviation 24.31
|
2.3 Scores on Scale
Standard Deviation 24.07
|
3.9 Scores on Scale
Standard Deviation 23.22
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C15D1
|
7.3 Scores on Scale
Standard Deviation 19.97
|
2.6 Scores on Scale
Standard Deviation 24.64
|
-4.2 Scores on Scale
Standard Deviation 11.79
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C18D1
|
5.0 Scores on Scale
Standard Deviation 20.74
|
4.4 Scores on Scale
Standard Deviation 24.34
|
-8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C22D1
|
6.5 Scores on Scale
Standard Deviation 21.37
|
6.1 Scores on Scale
Standard Deviation 16.70
|
0 Scores on Scale
Standard Deviation 0
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C26D1
|
6.3 Scores on Scale
Standard Deviation 21.48
|
0 Scores on Scale
Standard Deviation 20.41
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C30D1
|
13.3 Scores on Scale
Standard Deviation 21.52
|
-4.8 Scores on Scale
Standard Deviation 22.10
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C34D1
|
13.3 Scores on Scale
Standard Deviation 19.94
|
0 Scores on Scale
Standard Deviation 27.22
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C38D1
|
2.6 Scores on Scale
Standard Deviation 21.35
|
-11.1 Scores on Scale
Standard Deviation 50.18
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C42D1
|
4.2 Scores on Scale
Standard Deviation 11.79
|
-8.3 Scores on Scale
Standard Deviation 16.67
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C46D1
|
5.6 Scores on Scale
Standard Deviation 13.61
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C50D1
|
5.6 Scores on Scale
Standard Deviation 25.09
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C54D1
|
0 Scores on Scale
Standard Deviation 29.81
|
-33.3 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C58D1
|
0 Scores on Scale
Standard Deviation 33.33
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C62D1
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to C66D1
|
—
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to EOT (~216 weeks)
|
6.8 Scores on Scale
Standard Deviation 27.27
|
6.6 Scores on Scale
Standard Deviation 25.20
|
-2.6 Scores on Scale
Standard Deviation 23.23
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to SFU D30 (~220 weeks)
|
7.6 Scores on Scale
Standard Deviation 33.42
|
6.7 Scores on Scale
Standard Deviation 26.37
|
5.8 Scores on Scale
Standard Deviation 27.80
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Arm or Shoulder, CFB to SFU D90 (~229 weeks)
|
-7.1 Scores on Scale
Standard Deviation 35.03
|
0 Scores on Scale
Standard Deviation 33.33
|
10.4 Scores on Scale
Standard Deviation 29.11
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C2D1
|
0.2 Scores on Scale
Standard Deviation 28.09
|
-0.3 Scores on Scale
Standard Deviation 25.73
|
2.4 Scores on Scale
Standard Deviation 25.31
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C3D1
|
0.5 Scores on Scale
Standard Deviation 28.04
|
-3.3 Scores on Scale
Standard Deviation 27.61
|
1.2 Scores on Scale
Standard Deviation 30.37
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C4D1
|
-1.6 Scores on Scale
Standard Deviation 26.35
|
-1.7 Scores on Scale
Standard Deviation 29.37
|
-1.0 Scores on Scale
Standard Deviation 29.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C5D1
|
2.5 Scores on Scale
Standard Deviation 30.53
|
-0.3 Scores on Scale
Standard Deviation 30.43
|
-1.2 Scores on Scale
Standard Deviation 30.35
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C6D1
|
1.5 Scores on Scale
Standard Deviation 29.39
|
0.3 Scores on Scale
Standard Deviation 31.77
|
4.0 Scores on Scale
Standard Deviation 28.28
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C9D1
|
5.5 Scores on Scale
Standard Deviation 29.09
|
-2.1 Scores on Scale
Standard Deviation 30.16
|
2.3 Scores on Scale
Standard Deviation 26.62
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C12D1
|
2.8 Scores on Scale
Standard Deviation 25.04
|
-1.7 Scores on Scale
Standard Deviation 27.52
|
5.9 Scores on Scale
Standard Deviation 24.25
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C15D1
|
-1.8 Scores on Scale
Standard Deviation 23.50
|
1.7 Scores on Scale
Standard Deviation 27.52
|
4.2 Scores on Scale
Standard Deviation 21.36
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C18D1
|
2.5 Scores on Scale
Standard Deviation 15.81
|
-3.3 Scores on Scale
Standard Deviation 33.16
|
8.3 Scores on Scale
Standard Deviation 16.67
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C22D1
|
2.4 Scores on Scale
Standard Deviation 18.84
|
-10.6 Scores on Scale
Standard Deviation 23.87
|
16.7 Scores on Scale
Standard Deviation 23.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C26D1
|
5.4 Scores on Scale
Standard Deviation 31.15
|
-15.7 Scores on Scale
Standard Deviation 37.49
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C30D1
|
2.7 Scores on Scale
Standard Deviation 28.74
|
-4.8 Scores on Scale
Standard Deviation 28.81
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C34D1
|
1.7 Scores on Scale
Standard Deviation 17.01
|
-14.3 Scores on Scale
Standard Deviation 17.82
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C38D1
|
7.7 Scores on Scale
Standard Deviation 27.74
|
-11.1 Scores on Scale
Standard Deviation 34.43
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C42D1
|
-4.2 Scores on Scale
Standard Deviation 21.36
|
-8.3 Scores on Scale
Standard Deviation 16.67
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C46D1
|
0 Scores on Scale
Standard Deviation 21.08
|
-16.7 Scores on Scale
Standard Deviation 23.57
|
33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C50D1
|
0 Scores on Scale
Standard Deviation 21.08
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C54D1
|
-5.6 Scores on Scale
Standard Deviation 25.09
|
-33.3 Scores on Scale
Standard Deviation 0
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C58D1
|
11.1 Scores on Scale
Standard Deviation 19.25
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C62D1
|
16.7 Scores on Scale
Standard Deviation 23.57
|
-33.3 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to C66D1
|
—
|
0 Scores on Scale
Standard Deviation NA
Standard Deviation is not evaluable for a single participant.
|
—
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to EOT (~216 weeks)
|
5.4 Scores on Scale
Standard Deviation 31.18
|
6.2 Scores on Scale
Standard Deviation 32.75
|
6.7 Scores on Scale
Standard Deviation 33.95
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to SFU D30(~220 weeks)
|
2.9 Scores on Scale
Standard Deviation 29.56
|
1.7 Scores on Scale
Standard Deviation 31.48
|
8.7 Scores on Scale
Standard Deviation 27.00
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment
Pain in Other Parts, CFB to SFU D90 (~229 weeks)
|
4.8 Scores on Scale
Standard Deviation 25.68
|
4.3 Scores on Scale
Standard Deviation 32.26
|
8.3 Scores on Scale
Standard Deviation 25.82
|
SECONDARY outcome
Timeframe: Baseline (Day-1) up to Cycle 1 Day 1Population: Safety (SAF) population included all participants who received at least 1 dose of study treatment. ECGs after baseline were carried out only when clinically necessary, resulting in limited post-baseline data; only participants with available post-baseline ECGs were included in the Overall Number of Participants Analyzed.
ECGs were recorded after the participants were in a supine or semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes. ECG findings are summarized as clinically significant change from baseline worst case hierarchy: Yes \> No \> Not Applicable (NA).
Outcome measures
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=28 Participants
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=19 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=18 Participants
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
Yes
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
NA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
No
|
20 Participants
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 329 weeksA TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksA TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksNumber of participants using concomitant medications will be presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksBlood samples will be collected for the analysis of hematology parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksBlood samples will be collected for the analysis of Clinical Chemistry parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksBlood samples will be collected for the analysis of thyroid function
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksUrine samples will be collected to analyze urine specific gravity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksVital signs will be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1) and Up to 281 weeksVital signs will be assessed and presented
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 329 weeksPerformance status will be assessed using the ECOG performance status scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 234 weeksPopulation: As pre-specified in the Statistical Analysis Plan, no planned analysis was generated for physical examination, and thus no data was collected in the eCRF or captured in the clinical database.
Number of participants with abnormal physical examinations will be presented
Outcome measures
Outcome data not reported
Adverse Events
Cobolimab + Dostarlimab + Docetaxel (Arm A)
Serious events: 102 serious events
Other events: 285 other events
Deaths: 227 deaths
Dostarlimab + Docetaxel (Arm B)
Serious events: 126 serious events
Other events: 276 other events
Deaths: 236 deaths
Docetaxel (Arm C)
Serious events: 52 serious events
Other events: 136 other events
Deaths: 116 deaths
Serious adverse events
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=302 participants at risk
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Dostarlimab + Docetaxel (Arm B)
n=295 participants at risk
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=144 participants at risk
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
2/302 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
9/302 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.1%
15/295 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
4/302 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.7%
5/295 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.99%
3/302 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.0%
3/295 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.66%
2/302 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
1.3%
4/302 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Generalised oedema
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Inflammation
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.33%
1/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.0%
3/295 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
4/295 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
4/295 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Febrile infection
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Infection
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
4/295 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Neutropenic sepsis
|
0.99%
3/302 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Periorbital cellulitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
6.3%
19/302 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
8.1%
24/295 • Number of events 29 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
8.3%
12/144 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Prostatitis Escherichia coli
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
4/302 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.0%
3/295 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.99%
3/302 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
4/295 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.33%
1/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.0%
3/295 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
4/302 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.0%
3/295 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.8%
4/144 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
4/302 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
4/295 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.7%
5/295 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
6/302 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.0%
6/295 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
5/302 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.66%
2/302 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
4/295 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.33%
1/302 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.68%
2/295 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/295 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.69%
1/144 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/302 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.34%
1/295 • Number of events 1 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
0.00%
0/144 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Cobolimab + Dostarlimab + Docetaxel (Arm A)
n=302 participants at risk
Participants with advanced non-small cell lung cancer (NSCLC) who had progressed on prior anti-programmed death ligand 1 (anti-PD L1) therapy and chemotherapy received 300 milligram (mg) intravenous (IV) infusion of cobolimab followed by 500 mg IV infusion of dostarlimab every 3 weeks (Q3W) until disease progression, unacceptable toxicity, participant withdrawal, the investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel as IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Dostarlimab + Docetaxel (Arm B)
n=295 participants at risk
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 500 mg dostarlimab IV infusion Q3W until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Additionally, participants received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
Docetaxel (Arm C)
n=144 participants at risk
Participants with advanced NSCLC who had progressed on prior anti PD-L1 therapy and chemotherapy received 75 mg/m\^2 docetaxel IV infusion Q3W for a minimum of 4 cycles (each cycle of 21 days) or until disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
34.8%
105/302 • Number of events 165 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
31.5%
93/295 • Number of events 149 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
28.5%
41/144 • Number of events 66 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
25/302 • Number of events 28 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.4%
16/295 • Number of events 18 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
9.7%
14/144 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.5%
95/302 • Number of events 122 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
26.1%
77/295 • Number of events 96 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
26.4%
38/144 • Number of events 60 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
17/302 • Number of events 18 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
6.1%
18/295 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
12.9%
39/302 • Number of events 48 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
13.6%
40/295 • Number of events 53 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
12.5%
18/144 • Number of events 21 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.8%
87/302 • Number of events 137 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
29.5%
87/295 • Number of events 129 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
25.7%
37/144 • Number of events 57 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
24.5%
74/302 • Number of events 92 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
23.1%
68/295 • Number of events 98 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
20.8%
30/144 • Number of events 45 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
6.3%
19/302 • Number of events 26 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
9.2%
27/295 • Number of events 34 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
7.6%
11/144 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
32/302 • Number of events 36 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
10.8%
32/295 • Number of events 43 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
6.9%
10/144 • Number of events 13 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
23.2%
70/302 • Number of events 127 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
26.8%
79/295 • Number of events 141 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
25.0%
36/144 • Number of events 61 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
29.5%
89/302 • Number of events 147 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
29.8%
88/295 • Number of events 158 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
27.8%
40/144 • Number of events 61 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
11.9%
36/302 • Number of events 45 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
7.5%
22/295 • Number of events 27 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
8.3%
12/144 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
8.9%
27/302 • Number of events 39 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
7.1%
21/295 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
11.1%
16/144 • Number of events 19 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
10.3%
31/302 • Number of events 42 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
9.2%
27/295 • Number of events 38 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
8.3%
12/144 • Number of events 17 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
9.9%
30/302 • Number of events 32 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
6.1%
18/295 • Number of events 18 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.6%
8/144 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
4.3%
13/302 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
7.8%
23/295 • Number of events 31 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.9%
7/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
13/302 • Number of events 17 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
6.1%
18/295 • Number of events 27 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.2%
6/144 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
13/302 • Number of events 17 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.8%
17/295 • Number of events 28 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.2%
6/144 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
12/302 • Number of events 19 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.4%
16/295 • Number of events 25 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.2%
6/144 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
5.3%
16/302 • Number of events 19 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.4%
13/295 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
3.5%
5/144 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.0%
21/302 • Number of events 32 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
3.7%
11/295 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
7.6%
11/144 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
14.6%
44/302 • Number of events 95 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
14.9%
44/295 • Number of events 51 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
14.6%
21/144 • Number of events 30 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
9.3%
28/302 • Number of events 73 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
10.5%
31/295 • Number of events 45 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
10.4%
15/144 • Number of events 21 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.2%
61/302 • Number of events 77 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
23.4%
69/295 • Number of events 93 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
18.8%
27/144 • Number of events 33 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
15/302 • Number of events 46 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.1%
15/295 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.6%
8/144 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.0%
18/302 • Number of events 24 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.7%
8/295 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.2%
6/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
46/302 • Number of events 71 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
13.6%
40/295 • Number of events 51 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.6%
8/144 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
19/302 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
9.5%
28/295 • Number of events 29 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.2%
6/144 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
30/302 • Number of events 35 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
14.9%
44/295 • Number of events 60 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
12.5%
18/144 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
16/302 • Number of events 19 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.1%
12/295 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.8%
4/144 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
3.3%
10/302 • Number of events 14 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
7.8%
23/295 • Number of events 28 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.9%
7/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
5.6%
17/302 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.4%
16/295 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
3.5%
5/144 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
11.6%
35/302 • Number of events 55 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
9.8%
29/295 • Number of events 40 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
16.7%
24/144 • Number of events 32 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
6.6%
20/302 • Number of events 27 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.1%
12/295 • Number of events 18 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.8%
4/144 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.0%
21/302 • Number of events 25 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
6.8%
20/295 • Number of events 28 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
2.1%
3/144 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
7.0%
21/302 • Number of events 24 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
6.4%
19/295 • Number of events 21 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.9%
7/144 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
44/302 • Number of events 54 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
16.3%
48/295 • Number of events 58 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
11.8%
17/144 • Number of events 19 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.2%
52/302 • Number of events 70 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
17.3%
51/295 • Number of events 63 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
18.8%
27/144 • Number of events 37 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.3%
10/302 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
5.4%
16/295 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
1.4%
2/144 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.8%
78/302 • Number of events 90 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
23.4%
69/295 • Number of events 79 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
27.8%
40/144 • Number of events 42 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.9%
33/302 • Number of events 55 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
12.9%
38/295 • Number of events 44 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.9%
7/144 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.9%
33/302 • Number of events 46 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
10.2%
30/295 • Number of events 41 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
4.9%
7/144 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to approximately 234 weeks. Safety data collection is still ongoing, and additional results will be provided within a year of study completion.
All-cause mortality is based on enrolled population. SAEs and non-SAEs are based on Safety (SAF) population which included all participants who received at least 1 dose of study treatment.
|
Additional Information
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