Trial Outcomes & Findings for AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. (NCT NCT02511106)
NCT ID: NCT02511106
Last Updated: 2026-01-05
Results Overview
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
682 participants
Primary outcome timeframe
Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Results posted on
2026-01-05
Participant Flow
A total of 682 Patients were randomized to treatment at 245 Centers in 25 Countries.
During the 28 day screening period, participants were enrolled based on the presence of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations in their tumor. At the time of enrolment, all participant were required to have central confirmation of EGFR mutation status per eligibility criteria (Exon 19 deletion or L858R mutation).
Participant milestones
| Measure |
AZD9291
Taken once daily
|
Placebo
Taken once daily
|
|---|---|---|
|
Overall Study
STARTED
|
339
|
343
|
|
Overall Study
Received Treatment
|
337
|
343
|
|
Overall Study
COMPLETED
|
261
|
234
|
|
Overall Study
NOT COMPLETED
|
78
|
109
|
Reasons for withdrawal
| Measure |
AZD9291
Taken once daily
|
Placebo
Taken once daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
24
|
21
|
|
Overall Study
Death
|
42
|
82
|
|
Overall Study
Ongoing study at data cut-off
|
3
|
2
|
|
Overall Study
Without specified reason
|
3
|
0
|
Baseline Characteristics
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
Baseline characteristics by cohort
| Measure |
AZD9291
n=339 Participants
Taken once daily
|
Placebo
n=343 Participants
Taken once daily
|
Total
n=682 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 Years
STANDARD_DEVIATION 10.3 • n=9667 Participants
|
61.6 Years
STANDARD_DEVIATION 10.5 • n=6597 Participants
|
62.1 Years
STANDARD_DEVIATION 10.4 • n=16264 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=9667 Participants
|
248 Participants
n=6597 Participants
|
478 Participants
n=16264 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=9667 Participants
|
95 Participants
n=6597 Participants
|
204 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
ASIAN (OTHER THAN CHINESE AND JAPANESE)
|
77 Participants
n=9667 Participants
|
65 Participants
n=6597 Participants
|
142 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
CHINESE
|
95 Participants
n=9667 Participants
|
100 Participants
n=6597 Participants
|
195 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
12 Participants
n=9667 Participants
|
9 Participants
n=6597 Participants
|
21 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
JAPANESE
|
47 Participants
n=9667 Participants
|
53 Participants
n=6597 Participants
|
100 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
1 Participants
n=9667 Participants
|
2 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
216 Participants
n=9667 Participants
|
218 Participants
n=6597 Participants
|
434 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
UNKNOWN OR NOT REPORTED
|
0 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
122 Participants
n=9667 Participants
|
122 Participants
n=6597 Participants
|
244 Participants
n=16264 Participants
|
|
Region of Enrollment
Australia
|
7 Participants
n=9667 Participants
|
9 Participants
n=6597 Participants
|
16 Participants
n=16264 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
|
Region of Enrollment
Brazil
|
8 Participants
n=9667 Participants
|
6 Participants
n=6597 Participants
|
14 Participants
n=16264 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=9667 Participants
|
3 Participants
n=6597 Participants
|
4 Participants
n=16264 Participants
|
|
Region of Enrollment
China
|
77 Participants
n=9667 Participants
|
82 Participants
n=6597 Participants
|
159 Participants
n=16264 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=9667 Participants
|
5 Participants
n=6597 Participants
|
12 Participants
n=16264 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=9667 Participants
|
16 Participants
n=6597 Participants
|
30 Participants
n=16264 Participants
|
|
Region of Enrollment
France
|
4 Participants
n=9667 Participants
|
5 Participants
n=6597 Participants
|
9 Participants
n=16264 Participants
|
|
Region of Enrollment
Hong Kong, S.A.R., China
|
4 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
8 Participants
n=16264 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
2 Participants
n=16264 Participants
|
|
Region of Enrollment
Israel
|
9 Participants
n=9667 Participants
|
3 Participants
n=6597 Participants
|
12 Participants
n=16264 Participants
|
|
Region of Enrollment
Italy
|
15 Participants
n=9667 Participants
|
17 Participants
n=6597 Participants
|
32 Participants
n=16264 Participants
|
|
Region of Enrollment
Japan
|
46 Participants
n=9667 Participants
|
53 Participants
n=6597 Participants
|
99 Participants
n=16264 Participants
|
|
Region of Enrollment
Poland
|
4 Participants
n=9667 Participants
|
9 Participants
n=6597 Participants
|
13 Participants
n=16264 Participants
|
|
Region of Enrollment
Romania
|
2 Participants
n=9667 Participants
|
2 Participants
n=6597 Participants
|
4 Participants
n=16264 Participants
|
|
Region of Enrollment
Russia
|
43 Participants
n=9667 Participants
|
39 Participants
n=6597 Participants
|
82 Participants
n=16264 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
2 Participants
n=16264 Participants
|
|
Region of Enrollment
Thailand
|
16 Participants
n=9667 Participants
|
17 Participants
n=6597 Participants
|
33 Participants
n=16264 Participants
|
|
Region of Enrollment
Turkey
|
3 Participants
n=9667 Participants
|
8 Participants
n=6597 Participants
|
11 Participants
n=16264 Participants
|
|
Region of Enrollment
Taiwan, China
|
24 Participants
n=9667 Participants
|
22 Participants
n=6597 Participants
|
46 Participants
n=16264 Participants
|
|
Region of Enrollment
Ukraine
|
2 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=9667 Participants
|
8 Participants
n=6597 Participants
|
21 Participants
n=16264 Participants
|
|
Region of Enrollment
Viet Nam
|
11 Participants
n=9667 Participants
|
13 Participants
n=6597 Participants
|
24 Participants
n=16264 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
27 Participants
n=9667 Participants
|
18 Participants
n=6597 Participants
|
45 Participants
n=16264 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)Population: Full Analysis Set (FAS) stage IIA-IIIA patients
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=233 Participants
Taken once daily
|
Placebo Tablet
n=237 Participants
Taken once daily
|
|---|---|---|
|
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
|
65.8 Months
Interval 54.4 to
Insufficient DFS events to estimate upper 95% confidence interval (Kaplan Meier analysis)
|
21.9 Months
Interval 16.6 to 27.5
|
PRIMARY outcome
Timeframe: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)Population: Full Analysis Set (FAS) stage IB-IIIA patients
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=339 Participants
Taken once daily
|
Placebo Tablet
n=343 Participants
Taken once daily
|
|---|---|---|
|
Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
|
65.8 Months
Interval 61.7 to
Insufficient DFS events to estimate upper 95% confidence interval (Kaplan Meier analysis)
|
28.1 Months
Interval 22.1 to 35.0
|
SECONDARY outcome
Timeframe: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.Population: Full analysis set (FAS) stage IIA-IIIA patients
Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=233 Participants
Taken once daily
|
Placebo Tablet
n=237 Participants
Taken once daily
|
|---|---|---|
|
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
DFS rate at 2 years (%)
|
90.0 Percentage of participants
Interval 85.2 to 93.3
|
46.1 Percentage of participants
Interval 39.6 to 52.4
|
|
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
DFS rate at 3 years (%)
|
83.5 Percentage of participants
Interval 77.8 to 87.8
|
33.8 Percentage of participants
Interval 27.8 to 40.0
|
|
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
DFS rate at 5 years (%)
|
53.0 Percentage of participants
Interval 43.0 to 62.1
|
24.9 Percentage of participants
Interval 19.0 to 31.2
|
SECONDARY outcome
Timeframe: Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.Population: Full analysis set (FAS) stage IB-IIIA patients
Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=339 Participants
Taken once daily
|
Placebo Tablet
n=343 Participants
Taken once daily
|
|---|---|---|
|
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
DFS rate at 2 years (%)
|
90.1 Percentage of participants
Interval 86.2 to 92.9
|
54.5 Percentage of participants
Interval 49.0 to 59.7
|
|
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
DFS rate at 3 years (%)
|
84.5 Percentage of participants
Interval 79.9 to 88.1
|
44.4 Percentage of participants
Interval 39.0 to 49.7
|
|
Disease Free Survival (DFS) Rate at 2, 3 and 5 Years
DFS rate at 5 years (%)
|
60.9 Percentage of participants
Interval 53.1 to 67.8
|
33.6 Percentage of participants
Interval 28.0 to 39.2
|
SECONDARY outcome
Timeframe: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)Population: Full Analysis Set (FAS) stage IIA-IIIA patients
Defined as the time from the date of randomization until date of death due to any cause.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=233 Participants
Taken once daily
|
Placebo Tablet
n=237 Participants
Taken once daily
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Insufficient OS events to estimate median and 95% confidence interval (Kaplan Meier analysis)
|
NA Months
Insufficient OS events to estimate median and 95% confidence interval (Kaplan Meier analysis)
|
SECONDARY outcome
Timeframe: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)Population: Full Analysis Set (FAS) stage IB-IIIA patients
Defined as the time from the date of randomization until date of death due to any cause.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=339 Participants
Taken once daily
|
Placebo Tablet
n=343 Participants
Taken once daily
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Insufficient OS events to estimate median and 95% confidence interval (Kaplan Meier analysis)
|
NA Months
Insufficient OS events to estimate median and 95% confidence interval (Kaplan Meier analysis)
|
SECONDARY outcome
Timeframe: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.Population: Full Analysis Set (FAS) stage IIA-IIIA patients
Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=233 Participants
Taken once daily
|
Placebo Tablet
n=237 Participants
Taken once daily
|
|---|---|---|
|
Overall Survival Rate at 2, 3 and 5 Years
OS rate at 2 years (%)
|
99.5 Percentage of participants
Interval 96.8 to 99.9
|
92.6 Percentage of participants
Interval 88.3 to 95.3
|
|
Overall Survival Rate at 2, 3 and 5 Years
OS rate at 3 years (%)
|
94.1 Percentage of participants
Interval 90.1 to 96.5
|
85.9 Percentage of participants
Interval 80.6 to 89.8
|
|
Overall Survival Rate at 2, 3 and 5 Years
OS rate at 5 years (%)
|
85.0 Percentage of participants
Interval 79.3 to 89.2
|
72.6 Percentage of participants
Interval 66.0 to 78.1
|
SECONDARY outcome
Timeframe: Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.Population: Full Analysis Set (FAS) stage IB-IIIA patients
Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=339 Participants
Taken once daily
|
Placebo Tablet
n=343 Participants
Taken once daily
|
|---|---|---|
|
Overall Survival Rate at 2, 3 and 5 Years
OS rate at 2 years (%)
|
99.4 Percentage of participants
Interval 97.5 to 99.8
|
94.3 Percentage of participants
Interval 91.2 to 96.3
|
|
Overall Survival Rate at 2, 3 and 5 Years
OS rate at 3 years (%)
|
95.3 Percentage of participants
Interval 92.3 to 97.1
|
88.8 Percentage of participants
Interval 84.9 to 91.8
|
|
Overall Survival Rate at 2, 3 and 5 Years
OS rate at 5 years (%)
|
87.6 Percentage of participants
Interval 83.3 to 90.9
|
77.7 Percentage of participants
Interval 72.7 to 81.9
|
SECONDARY outcome
Timeframe: Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.Population: Full Analysis Set (FAS)
Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=339 Participants
Taken once daily
|
Placebo Tablet
n=343 Participants
Taken once daily
|
|---|---|---|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Bodily Pain
|
1.026 Unit on a scale
Standard Deviation 9.448
|
1.442 Unit on a scale
Standard Deviation 8.854
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Bodily Pain
|
1.521 Unit on a scale
Standard Deviation 9.171
|
1.462 Unit on a scale
Standard Deviation 9.279
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Bodily Pain
|
2.032 Unit on a scale
Standard Deviation 10.226
|
2.438 Unit on a scale
Standard Deviation 10.077
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Bodily Pain
|
2.471 Unit on a scale
Standard Deviation 9.787
|
2.335 Unit on a scale
Standard Deviation 9.566
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Bodily Pain
|
2.326 Unit on a scale
Standard Deviation 10.865
|
2.921 Unit on a scale
Standard Deviation 10.153
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Bodily Pain
|
2.906 Unit on a scale
Standard Deviation 10.181
|
2.778 Unit on a scale
Standard Deviation 11.295
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Bodily Pain
|
3.045 Unit on a scale
Standard Deviation 11.410
|
3.324 Unit on a scale
Standard Deviation 10.258
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Bodily Pain
|
2.552 Unit on a scale
Standard Deviation 11.994
|
3.116 Unit on a scale
Standard Deviation 10.692
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - General Health Perceptions
|
-0.597 Unit on a scale
Standard Deviation 8.319
|
0.343 Unit on a scale
Standard Deviation 7.497
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - General Health Perceptions
|
-0.079 Unit on a scale
Standard Deviation 8.910
|
0.763 Unit on a scale
Standard Deviation 8.122
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - General Health Perceptions
|
0.103 Unit on a scale
Standard Deviation 8.029
|
1.042 Unit on a scale
Standard Deviation 8.416
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - General Health Perceptions
|
0.275 Unit on a scale
Standard Deviation 7.958
|
2.339 Unit on a scale
Standard Deviation 8.197
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - General Health Perceptions
|
-0.119 Unit on a scale
Standard Deviation 8.195
|
1.818 Unit on a scale
Standard Deviation 7.903
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - General Health Perceptions
|
-0.368 Unit on a scale
Standard Deviation 8.461
|
0.964 Unit on a scale
Standard Deviation 8.518
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - General Health Perceptions
|
0.209 Unit on a scale
Standard Deviation 8.671
|
1.342 Unit on a scale
Standard Deviation 8.789
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - General Health Perceptions
|
-0.128 Unit on a scale
Standard Deviation 8.987
|
2.166 Unit on a scale
Standard Deviation 8.670
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Mental Health
|
0.928 Unit on a scale
Standard Deviation 8.538
|
1.892 Unit on a scale
Standard Deviation 8.497
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Mental Health
|
1.249 Unit on a scale
Standard Deviation 8.780
|
1.275 Unit on a scale
Standard Deviation 9.660
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Mental Health
|
2.456 Unit on a scale
Standard Deviation 8.920
|
2.234 Unit on a scale
Standard Deviation 8.676
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Mental Health
|
1.540 Unit on a scale
Standard Deviation 9.029
|
2.011 Unit on a scale
Standard Deviation 8.954
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Mental Health
|
1.352 Unit on a scale
Standard Deviation 8.560
|
2.101 Unit on a scale
Standard Deviation 8.986
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Mental Health
|
0.723 Unit on a scale
Standard Deviation 9.738
|
2.307 Unit on a scale
Standard Deviation 10.139
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Mental Health
|
0.517 Unit on a scale
Standard Deviation 9.609
|
1.428 Unit on a scale
Standard Deviation 8.914
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Mental Health
|
0.386 Unit on a scale
Standard Deviation 10.215
|
2.000 Unit on a scale
Standard Deviation 9.651
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Physical functioning
|
-0.314 Unit on a scale
Standard Deviation 6.762
|
0.898 Unit on a scale
Standard Deviation 6.646
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Physical functioning
|
0.494 Unit on a scale
Standard Deviation 6.783
|
0.923 Unit on a scale
Standard Deviation 7.014
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Physical functioning
|
0.940 Unit on a scale
Standard Deviation 7.595
|
1.914 Unit on a scale
Standard Deviation 7.899
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Physical functioning
|
1.079 Unit on a scale
Standard Deviation 6.725
|
2.042 Unit on a scale
Standard Deviation 7.283
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Physical functioning
|
0.637 Unit on a scale
Standard Deviation 8.220
|
2.016 Unit on a scale
Standard Deviation 7.048
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Physical functioning
|
1.449 Unit on a scale
Standard Deviation 7.207
|
2.540 Unit on a scale
Standard Deviation 7.424
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Physical functioning
|
1.869 Unit on a scale
Standard Deviation 6.767
|
1.939 Unit on a scale
Standard Deviation 8.238
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Physical functioning
|
0.997 Unit on a scale
Standard Deviation 7.537
|
2.187 Unit on a scale
Standard Deviation 8.293
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Role Limitations - Emotional
|
0.381 Unit on a scale
Standard Deviation 10.413
|
2.333 Unit on a scale
Standard Deviation 11.168
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Role Limitations - Emotional
|
0.858 Unit on a scale
Standard Deviation 11.317
|
1.678 Unit on a scale
Standard Deviation 11.571
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Role Limitations - Emotional
|
2.179 Unit on a scale
Standard Deviation 11.131
|
2.628 Unit on a scale
Standard Deviation 10.952
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Role Limitations - Emotional
|
1.410 Unit on a scale
Standard Deviation 11.861
|
1.860 Unit on a scale
Standard Deviation 11.424
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Role Limitations - Emotional
|
1.657 Unit on a scale
Standard Deviation 12.405
|
1.899 Unit on a scale
Standard Deviation 12.379
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Role Limitations - Emotional
|
1.765 Unit on a scale
Standard Deviation 11.966
|
2.360 Unit on a scale
Standard Deviation 12.663
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Role Limitations - Emotional
|
1.654 Unit on a scale
Standard Deviation 12.081
|
2.532 Unit on a scale
Standard Deviation 13.113
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Role Limitations - Emotional
|
0.519 Unit on a scale
Standard Deviation 12.351
|
2.201 Unit on a scale
Standard Deviation 13.022
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Role Limitations - Physical
|
1.056 Unit on a scale
Standard Deviation 9.263
|
2.915 Unit on a scale
Standard Deviation 8.977
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Role Limitations - Physical
|
1.727 Unit on a scale
Standard Deviation 10.265
|
4.063 Unit on a scale
Standard Deviation 9.295
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Role Limitations - Physical
|
3.437 Unit on a scale
Standard Deviation 10.592
|
5.332 Unit on a scale
Standard Deviation 9.663
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Role Limitations - Physical
|
3.581 Unit on a scale
Standard Deviation 11.037
|
5.424 Unit on a scale
Standard Deviation 9.670
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Role Limitations - Physical
|
3.240 Unit on a scale
Standard Deviation 10.807
|
5.321 Unit on a scale
Standard Deviation 9.997
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Role Limitations - Physical
|
4.717 Unit on a scale
Standard Deviation 11.238
|
5.348 Unit on a scale
Standard Deviation 11.395
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Role Limitations - Physical
|
3.525 Unit on a scale
Standard Deviation 10.860
|
5.444 Unit on a scale
Standard Deviation 10.547
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Role Limitations - Physical
|
3.151 Unit on a scale
Standard Deviation 11.378
|
5.572 Unit on a scale
Standard Deviation 10.954
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Social Function
|
1.391 Unit on a scale
Standard Deviation 9.615
|
3.164 Unit on a scale
Standard Deviation 9.171
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Social Function
|
2.634 Unit on a scale
Standard Deviation 9.526
|
3.433 Unit on a scale
Standard Deviation 10.348
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Social Function
|
3.731 Unit on a scale
Standard Deviation 9.919
|
4.170 Unit on a scale
Standard Deviation 10.156
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Social Function
|
3.025 Unit on a scale
Standard Deviation 10.094
|
4.802 Unit on a scale
Standard Deviation 10.351
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Social Function
|
3.651 Unit on a scale
Standard Deviation 10.011
|
4.405 Unit on a scale
Standard Deviation 10.790
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Social Function
|
3.297 Unit on a scale
Standard Deviation 10.723
|
4.386 Unit on a scale
Standard Deviation 11.355
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Social Function
|
2.582 Unit on a scale
Standard Deviation 10.638
|
3.912 Unit on a scale
Standard Deviation 10.929
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Social Function
|
2.423 Unit on a scale
Standard Deviation 10.658
|
4.351 Unit on a scale
Standard Deviation 12.144
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Vitality
|
0.570 Unit on a scale
Standard Deviation 7.987
|
2.344 Unit on a scale
Standard Deviation 8.207
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Vitality
|
0.630 Unit on a scale
Standard Deviation 8.996
|
2.463 Unit on a scale
Standard Deviation 9.461
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Vitality
|
2.231 Unit on a scale
Standard Deviation 9.209
|
3.029 Unit on a scale
Standard Deviation 8.972
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Vitality
|
1.082 Unit on a scale
Standard Deviation 9.387
|
3.815 Unit on a scale
Standard Deviation 8.869
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Vitality
|
1.147 Unit on a scale
Standard Deviation 9.052
|
3.474 Unit on a scale
Standard Deviation 9.071
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Vitality
|
1.139 Unit on a scale
Standard Deviation 9.458
|
3.224 Unit on a scale
Standard Deviation 9.122
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Vitality
|
0.386 Unit on a scale
Standard Deviation 9.724
|
2.070 Unit on a scale
Standard Deviation 9.285
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Vitality
|
0.825 Unit on a scale
Standard Deviation 9.342
|
2.970 Unit on a scale
Standard Deviation 8.831
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Mental Component Summary
|
0.986 Unit on a scale
Standard Deviation 8.068
|
2.603 Unit on a scale
Standard Deviation 8.965
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Mental Component Summary
|
1.333 Unit on a scale
Standard Deviation 8.919
|
1.936 Unit on a scale
Standard Deviation 10.152
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Mental Component Summary
|
2.788 Unit on a scale
Standard Deviation 9.301
|
2.757 Unit on a scale
Standard Deviation 9.141
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Mental Component Summary
|
1.434 Unit on a scale
Standard Deviation 9.635
|
2.577 Unit on a scale
Standard Deviation 9.116
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Mental Component Summary
|
1.823 Unit on a scale
Standard Deviation 9.439
|
2.415 Unit on a scale
Standard Deviation 10.023
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Mental Component Summary
|
1.027 Unit on a scale
Standard Deviation 10.286
|
2.554 Unit on a scale
Standard Deviation 10.548
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Mental Component Summary
|
0.580 Unit on a scale
Standard Deviation 9.994
|
1.870 Unit on a scale
Standard Deviation 9.857
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Mental Component Summary
|
0.322 Unit on a scale
Standard Deviation 10.077
|
2.269 Unit on a scale
Standard Deviation 10.647
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 12 - Physical Component Summary
|
0.161 Unit on a scale
Standard Deviation 6.341
|
1.144 Unit on a scale
Standard Deviation 6.078
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 24 - Physical Component Summary
|
0.878 Unit on a scale
Standard Deviation 7.009
|
1.938 Unit on a scale
Standard Deviation 6.643
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 48 - Physical Component Summary
|
1.356 Unit on a scale
Standard Deviation 6.800
|
2.797 Unit on a scale
Standard Deviation 7.497
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 72 - Physical Component Summary
|
1.989 Unit on a scale
Standard Deviation 6.941
|
3.360 Unit on a scale
Standard Deviation 6.985
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 96 - Physical Component Summary
|
1.497 Unit on a scale
Standard Deviation 7.591
|
3.343 Unit on a scale
Standard Deviation 6.792
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 120 - Physical Component Summary
|
2.611 Unit on a scale
Standard Deviation 7.291
|
3.175 Unit on a scale
Standard Deviation 8.210
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 144 - Physical Component Summary
|
2.635 Unit on a scale
Standard Deviation 7.374
|
3.353 Unit on a scale
Standard Deviation 8.042
|
|
Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.
Week 156 - Physical Component Summary
|
2.133 Unit on a scale
Standard Deviation 7.909
|
3.644 Unit on a scale
Standard Deviation 8.731
|
SECONDARY outcome
Timeframe: Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)Population: Pharmacokinetic analysis set
The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=325 Participants
Taken once daily
|
Placebo Tablet
Taken once daily
|
|---|---|---|
|
Plasma Concentrations of AZD9291
Week 4 - Pre-dose
|
380.2563 nM
Geometric Coefficient of Variation 60.4465
|
—
|
|
Plasma Concentrations of AZD9291
Week 4 - 0.5-1.5 hours
|
383.9142 nM
Geometric Coefficient of Variation 74.3191
|
—
|
|
Plasma Concentrations of AZD9291
Week 4 - 2-4 hours
|
463.0098 nM
Geometric Coefficient of Variation 56.3562
|
—
|
|
Plasma Concentrations of AZD9291
Week 24- Pre-dose
|
288.8266 nM
Geometric Coefficient of Variation 181.8255
|
—
|
|
Plasma Concentrations of AZD9291
Week 24 - 0.5-1.5 hours
|
303.8269 nM
Geometric Coefficient of Variation 116.9411
|
—
|
|
Plasma Concentrations of AZD9291
Week 24 - 2-4 hours
|
358.831 nM
Geometric Coefficient of Variation 116.0567
|
—
|
|
Plasma Concentrations of AZD9291
Week 48- Pre-dose
|
301.7346 nM
Geometric Coefficient of Variation 125.4901
|
—
|
|
Plasma Concentrations of AZD9291
Week 48 - 0.5-1.5 hours
|
311.3503 nM
Geometric Coefficient of Variation 101.1574
|
—
|
|
Plasma Concentrations of AZD9291
Week 48 - 2-4 hours
|
375.6666 nM
Geometric Coefficient of Variation 69.9838
|
—
|
|
Plasma Concentrations of AZD9291
Week 96- Pre-dose
|
287.5375 nM
Geometric Coefficient of Variation 95.6634
|
—
|
|
Plasma Concentrations of AZD9291
Week 96 - 0.5-1.5 hours
|
273.3198 nM
Geometric Coefficient of Variation 126.003
|
—
|
|
Plasma Concentrations of AZD9291
Week 96 - 2-4 hours
|
341.5805 nM
Geometric Coefficient of Variation 79.0578
|
—
|
SECONDARY outcome
Timeframe: From date of dosing to week 96 (approximately 24 months)Population: Pharmacokinetic analysis set
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=325 Participants
Taken once daily
|
Placebo Tablet
Taken once daily
|
|---|---|---|
|
Plasma Concentrations of AZ5104 Metabolites
Week 96 - 0.5-1.5 hours
|
36.9723 nM
Geometric Coefficient of Variation 101.2317
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 96 - 2-4 hours
|
39.8057 nM
Geometric Coefficient of Variation 78.0300
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 4 - Pre-dose
|
44.4619 nM
Geometric Coefficient of Variation 66.2108
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 4 - 0.5-1.5 hours
|
45.2280 nM
Geometric Coefficient of Variation 67.0500
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 4 - 2-4 hours
|
49.6081 nM
Geometric Coefficient of Variation 65.5757
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 24 - Pre-dose
|
38.7314 nM
Geometric Coefficient of Variation 111.0996
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 24 - 0.5-1.5 hours
|
39.1687 nM
Geometric Coefficient of Variation 86.1118
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 24 - 2-4 hours
|
41.3251 nM
Geometric Coefficient of Variation 99.2633
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 48 - Pre-dose
|
41.1778 nM
Geometric Coefficient of Variation 53.8923
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 48 - 0.5-1.5 hours
|
40.9276 nM
Geometric Coefficient of Variation 53.9916
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 48 - 2-4 hours
|
42.9143 nM
Geometric Coefficient of Variation 68.8102
|
—
|
|
Plasma Concentrations of AZ5104 Metabolites
Week 96 - Pre-dose
|
38.0205 nM
Geometric Coefficient of Variation 81.4442
|
—
|
SECONDARY outcome
Timeframe: From date of dosing to week 96 (approximately 24 months)Population: Pharmacokinetic analysis set
The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites
Outcome measures
| Measure |
AZD9291 80mg Tablet
n=325 Participants
Taken once daily
|
Placebo Tablet
Taken once daily
|
|---|---|---|
|
Plasma Concentrations of AZ7550 Metabolites
Week 4 - Pre-dose
|
44.3492 nM
Geometric Coefficient of Variation 56.5153
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 4 - 0.5-1.5 hours
|
44.7386 nM
Geometric Coefficient of Variation 55.0410
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 4 - 2-4 hours
|
48.0864 nM
Geometric Coefficient of Variation 61.8700
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 24 - 0.5-1.5 hours
|
40.9375 nM
Geometric Coefficient of Variation 65.8656
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 24 - 2-4 hours
|
44.1476 nM
Geometric Coefficient of Variation 60.2684
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 48 - Pre-dose
|
41.3862 nM
Geometric Coefficient of Variation 52.2259
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 48 - 0.5-1.5 hours
|
41.0467 nM
Geometric Coefficient of Variation 52.9773
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 48 - 2-4 hours
|
40.4486 nM
Geometric Coefficient of Variation 99.6574
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 96 - Pre-dose
|
28.1890 nM
Geometric Coefficient of Variation 180.0937
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 96 - 0.5-1.5 hours
|
30.2419 nM
Geometric Coefficient of Variation 155.4156
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 96 - 2-4 hours
|
33.9653 nM
Geometric Coefficient of Variation 79.2841
|
—
|
|
Plasma Concentrations of AZ7550 Metabolites
Week 24 - Pre-dose
|
40.7113 nM
Geometric Coefficient of Variation 75.3663
|
—
|
Adverse Events
AZD9291
Serious events: 68 serious events
Other events: 312 other events
Deaths: 42 deaths
Placebo
Serious events: 47 serious events
Other events: 262 other events
Deaths: 82 deaths
Serious adverse events
| Measure |
AZD9291
n=337 participants at risk
Description (Arm-group)
|
Placebo
n=343 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.30%
1/337 • Number of events 6 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Otolithiasis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.30%
1/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
0.59%
2/337 • Number of events 3 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
General disorders
Death
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
General disorders
Malaise
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Biliary tract infection
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Endocarditis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.5%
5/337 • Number of events 5 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.2%
4/343 • Number of events 4 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.59%
2/337 • Number of events 2 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/337 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone hypertrophy
|
0.30%
1/337 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
AZD9291
n=337 participants at risk
Description (Arm-group)
|
Placebo
n=343 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
23/337 • Number of events 26 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
10.8%
37/343 • Number of events 42 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
27/337 • Number of events 28 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
7.6%
26/343 • Number of events 37 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
26/337 • Number of events 29 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.5%
5/343 • Number of events 5 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
8.3%
28/337 • Number of events 38 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
7.9%
27/343 • Number of events 31 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
8.0%
27/337 • Number of events 31 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
9.6%
33/343 • Number of events 49 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.3%
18/337 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.0%
17/343 • Number of events 18 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
66/337 • Number of events 86 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
17.8%
61/343 • Number of events 74 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
21/337 • Number of events 26 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.5%
5/343 • Number of events 5 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
21/337 • Number of events 22 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
2.3%
8/343 • Number of events 8 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
12.2%
41/337 • Number of events 49 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.7%
16/343 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
24.9%
84/337 • Number of events 95 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
6.7%
23/343 • Number of events 25 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.5%
22/337 • Number of events 22 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.87%
3/343 • Number of events 3 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.8%
70/337 • Number of events 88 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
8.7%
30/343 • Number of events 42 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.1%
34/337 • Number of events 47 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
3.5%
12/343 • Number of events 13 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
22/337 • Number of events 29 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.1%
14/343 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.6%
19/337 • Number of events 26 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
4.2%
14/337 • Number of events 16 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.2%
18/343 • Number of events 21 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
5.9%
20/337 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
3.5%
12/343 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
28/337 • Number of events 41 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.5%
5/343 • Number of events 5 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
20/337 • Number of events 25 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.5%
5/343 • Number of events 6 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
21/337 • Number of events 29 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.2%
18/343 • Number of events 21 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.9%
158/337 • Number of events 309 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
20.7%
71/343 • Number of events 114 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
18/337 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.1%
14/343 • Number of events 14 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
20/337 • Number of events 44 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.7%
6/343 • Number of events 6 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.6%
39/337 • Number of events 82 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
2.9%
10/343 • Number of events 16 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.1%
34/337 • Number of events 37 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.5%
19/343 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
17.5%
59/337 • Number of events 102 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.4%
15/343 • Number of events 17 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
2.4%
8/337 • Number of events 10 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.2%
18/343 • Number of events 25 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
30/337 • Number of events 43 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.7%
16/343 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
5.3%
18/337 • Number of events 21 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.0%
17/343 • Number of events 27 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
9.5%
32/337 • Number of events 45 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.2%
18/343 • Number of events 20 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
21/337 • Number of events 31 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
3.6%
12/337 • Number of events 16 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
5.2%
18/343 • Number of events 24 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.0%
27/337 • Number of events 47 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.00%
0/343 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
5.3%
18/337 • Number of events 25 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
2.9%
10/343 • Number of events 11 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
6.2%
21/337 • Number of events 28 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.4%
15/343 • Number of events 16 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
14.8%
50/337 • Number of events 118 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
10.5%
36/343 • Number of events 74 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Paronychia
|
27.3%
92/337 • Number of events 145 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
1.5%
5/343 • Number of events 7 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.7%
53/337 • Number of events 83 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
11.1%
38/343 • Number of events 54 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
24/337 • Number of events 31 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
4.7%
16/343 • Number of events 21 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
21/337 • Number of events 31 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
7.6%
26/343 • Number of events 37 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
22/337 • Number of events 32 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
7.9%
27/343 • Number of events 33 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
9.2%
31/337 • Number of events 41 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
2.0%
7/343 • Number of events 9 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Electrocardiogram qt prolonged
|
8.9%
30/337 • Number of events 49 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
2.3%
8/343 • Number of events 9 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
7.7%
26/337 • Number of events 48 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.87%
3/343 • Number of events 4 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Platelet count decreased
|
6.2%
21/337 • Number of events 36 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.58%
2/343 • Number of events 3 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
10.4%
35/337 • Number of events 40 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
2.6%
9/343 • Number of events 10 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
7.4%
25/337 • Number of events 53 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
0.29%
1/343 • Number of events 1 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.5%
49/337 • Number of events 55 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
3.5%
12/343 • Number of events 12 • Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants. The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER