Trial Outcomes & Findings for Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). (NCT NCT05116189)
NCT ID: NCT05116189
Last Updated: 2026-03-09
Results Overview
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
643 participants
Primary outcome timeframe
Up to ~38 months
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
322
|
321
|
|
Overall Study
Treated
|
320
|
318
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
322
|
321
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Death
|
221
|
240
|
|
Overall Study
Ongoing
|
95
|
73
|
Baseline Characteristics
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=322 Participants
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=321 Participants
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 10.7 • n=68 Participants
|
60.6 years
STANDARD_DEVIATION 9.9 • n=69 Participants
|
60.8 years
STANDARD_DEVIATION 10.3 • n=137 Participants
|
|
Sex: Female, Male
Female
|
322 Participants
n=68 Participants
|
321 Participants
n=69 Participants
|
643 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=68 Participants
|
52 Participants
n=69 Participants
|
98 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
261 Participants
n=68 Participants
|
255 Participants
n=69 Participants
|
516 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=68 Participants
|
14 Participants
n=69 Participants
|
29 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
72 Participants
n=68 Participants
|
58 Participants
n=69 Participants
|
130 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=68 Participants
|
6 Participants
n=69 Participants
|
14 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=68 Participants
|
217 Participants
n=69 Participants
|
424 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=68 Participants
|
17 Participants
n=69 Participants
|
29 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=68 Participants
|
22 Participants
n=69 Participants
|
44 Participants
n=137 Participants
|
|
Investigator Choice to Use Bevacizumab
Yes
|
235 Participants
n=68 Participants
|
236 Participants
n=69 Participants
|
471 Participants
n=137 Participants
|
|
Investigator Choice to Use Bevacizumab
No
|
87 Participants
n=68 Participants
|
85 Participants
n=69 Participants
|
172 Participants
n=137 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
CPS <1
|
88 Participants
n=68 Participants
|
89 Participants
n=69 Participants
|
177 Participants
n=137 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
CPS 1 to <10
|
133 Participants
n=68 Participants
|
132 Participants
n=69 Participants
|
265 Participants
n=137 Participants
|
|
Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
CPS ≥10
|
101 Participants
n=68 Participants
|
100 Participants
n=69 Participants
|
201 Participants
n=137 Participants
|
|
Geographic Region
United States (US)
|
30 Participants
n=68 Participants
|
29 Participants
n=69 Participants
|
59 Participants
n=137 Participants
|
|
Geographic Region
European Union (EU)
|
149 Participants
n=68 Participants
|
151 Participants
n=69 Participants
|
300 Participants
n=137 Participants
|
|
Geographic Region
Rest of World (ROW)
|
143 Participants
n=68 Participants
|
141 Participants
n=69 Participants
|
284 Participants
n=137 Participants
|
PRIMARY outcome
Timeframe: Up to ~38 monthsPopulation: The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=234 Participants
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=232 Participants
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)
|
8.3 Months
Interval 7.0 to 9.5
|
7.2 Months
Interval 6.2 to 8.1
|
PRIMARY outcome
Timeframe: Up to ~38 monthsPopulation: The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=322 Participants
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=321 Participants
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
|
8.3 Months
Interval 7.2 to 8.6
|
6.4 Months
Interval 6.2 to 8.1
|
SECONDARY outcome
Timeframe: Up to ~38 monthsPopulation: The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=234 Participants
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=232 Participants
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
|
8.5 Months
Interval 8.1 to 10.4
|
7.6 Months
Interval 6.2 to 8.3
|
SECONDARY outcome
Timeframe: Up to ~38 monthsPopulation: The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in all participants is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Outcome measures
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=322 Participants
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=321 Participants
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants
|
8.4 Months
Interval 8.1 to 10.3
|
6.4 Months
Interval 6.2 to 8.2
|
SECONDARY outcome
Timeframe: Up to ~64 monthsOS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to ~64 monthsAn AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to ~64 monthsAn AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to ~64 monthsThe EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to ~64 monthsTTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to ~64 monthsThe EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to ~64 monthsTTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab + Paclitaxel ± Bevacizumab
Serious events: 178 serious events
Other events: 319 other events
Deaths: 225 deaths
Placebo + Paclitaxel ± Bevacizumab
Serious events: 122 serious events
Other events: 307 other events
Deaths: 244 deaths
Serious adverse events
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=320 participants at risk
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=318 participants at risk
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.9%
6/318 • Number of events 6 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.94%
3/320 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
1.6%
5/320 • Number of events 5 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Enteritis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
1.2%
4/320 • Number of events 6 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.9%
6/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
11/318 • Number of events 12 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.2%
4/320 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Proctitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
7/320 • Number of events 9 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.3%
4/318 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Subileus
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Superior mesenteric artery syndrome
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Administration site extravasation
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Adverse drug reaction
|
0.31%
1/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Catheter site erythema
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chest pain
|
0.94%
3/320 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Death
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
0.94%
3/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pain
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Peripheral swelling
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
2.5%
8/320 • Number of events 10 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Sudden death
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.94%
3/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Abdominal sepsis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Abscess limb
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Anal abscess
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Appendicitis perforated
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bacteraemia
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
2.2%
7/320 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.62%
2/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Clostridium difficile infection
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Device related infection
|
1.2%
4/320 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Fournier's gangrene
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gastrointestinal infection
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Herpes zoster
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Infection
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Neutropenic sepsis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Peritoneal abscess
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Peritonitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
4.4%
14/320 • Number of events 14 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.3%
4/318 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 4 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Psoas abscess
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
1.9%
6/320 • Number of events 6 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sinusitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Tooth infection
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Tracheobronchitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
15/320 • Number of events 17 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.9%
6/318 • Number of events 6 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.94%
3/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood phosphorus decreased
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Liver function test increased
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
2.2%
7/320 • Number of events 9 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
5/318 • Number of events 8 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Transaminases increased
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
0.62%
2/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
8/320 • Number of events 8 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.94%
3/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.31%
1/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Aphasia
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Embolic stroke
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.94%
3/320 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.63%
2/318 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
9/320 • Number of events 9 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
7/318 • Number of events 7 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Surgical and medical procedures
Assisted suicide
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.94%
3/318 • Number of events 3 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Haematoma
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
May-Thurner syndrome
|
0.31%
1/320 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Shock
|
0.00%
0/320 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.31%
1/318 • Number of events 1 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Vena cava thrombosis
|
0.62%
2/320 • Number of events 2 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/318 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab + Paclitaxel ± Bevacizumab
n=320 participants at risk
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
Placebo + Paclitaxel ± Bevacizumab
n=318 participants at risk
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
52.8%
169/320 • Number of events 365 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
46.5%
148/318 • Number of events 263 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.5%
24/320 • Number of events 77 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
27/318 • Number of events 100 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.8%
76/320 • Number of events 186 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
25.5%
81/318 • Number of events 205 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
17.8%
57/320 • Number of events 67 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.0%
19/318 • Number of events 23 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
24/320 • Number of events 30 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
26/318 • Number of events 29 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
71/320 • Number of events 95 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
25.8%
82/318 • Number of events 109 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
18/320 • Number of events 22 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.3%
20/318 • Number of events 31 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
23.8%
76/320 • Number of events 103 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
24.8%
79/318 • Number of events 102 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.4%
139/320 • Number of events 285 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
39.6%
126/318 • Number of events 252 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
21/320 • Number of events 26 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.8%
28/318 • Number of events 32 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.4%
30/320 • Number of events 32 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
16/318 • Number of events 19 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
40.6%
130/320 • Number of events 229 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
35.8%
114/318 • Number of events 170 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
17.5%
56/320 • Number of events 77 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
10.4%
33/318 • Number of events 40 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
72/320 • Number of events 145 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
23.0%
73/318 • Number of events 104 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
18.8%
60/320 • Number of events 95 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
20.4%
65/318 • Number of events 91 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
40.3%
129/320 • Number of events 163 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
37.4%
119/318 • Number of events 147 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Influenza like illness
|
8.4%
27/320 • Number of events 34 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.7%
15/318 • Number of events 18 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
7.8%
25/320 • Number of events 29 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
16/318 • Number of events 52 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
10.6%
34/320 • Number of events 45 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
27/318 • Number of events 30 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
17.2%
55/320 • Number of events 65 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
13.5%
43/318 • Number of events 50 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
19.4%
62/320 • Number of events 95 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
11.6%
37/318 • Number of events 46 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
13.4%
43/320 • Number of events 47 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.8%
47/318 • Number of events 48 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
28/320 • Number of events 37 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
7.2%
23/318 • Number of events 27 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Paronychia
|
7.5%
24/320 • Number of events 33 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.8%
28/318 • Number of events 29 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sinusitis
|
5.6%
18/320 • Number of events 20 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
2.2%
7/318 • Number of events 11 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
32/320 • Number of events 45 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
11.0%
35/318 • Number of events 41 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
26.6%
85/320 • Number of events 172 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
21.7%
69/318 • Number of events 110 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
17.2%
55/320 • Number of events 68 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
10.4%
33/318 • Number of events 58 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
14.4%
46/320 • Number of events 75 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
10.1%
32/318 • Number of events 48 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.9%
22/320 • Number of events 30 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
18/318 • Number of events 21 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
8.1%
26/320 • Number of events 39 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
16/318 • Number of events 23 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
9.4%
30/320 • Number of events 62 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
18/318 • Number of events 46 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
28.7%
92/320 • Number of events 520 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
22.3%
71/318 • Number of events 335 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
5.6%
18/320 • Number of events 35 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.1%
10/318 • Number of events 33 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
11.9%
38/320 • Number of events 63 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.7%
15/318 • Number of events 15 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
24.4%
78/320 • Number of events 467 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
18.6%
59/318 • Number of events 317 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.4%
75/320 • Number of events 103 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
19.2%
61/318 • Number of events 70 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.6%
21/320 • Number of events 41 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
7.9%
25/318 • Number of events 49 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.4%
43/320 • Number of events 77 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.9%
22/318 • Number of events 24 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.6%
21/320 • Number of events 29 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.8%
12/318 • Number of events 22 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.6%
34/320 • Number of events 58 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.8%
28/318 • Number of events 48 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.6%
53/320 • Number of events 99 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
15.1%
48/318 • Number of events 80 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.4%
43/320 • Number of events 61 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
9.1%
29/318 • Number of events 46 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
55/320 • Number of events 79 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.8%
47/318 • Number of events 66 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.4%
46/320 • Number of events 52 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.2%
45/318 • Number of events 52 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
39/320 • Number of events 44 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
10.7%
34/318 • Number of events 49 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
29/320 • Number of events 36 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.8%
28/318 • Number of events 39 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
10.3%
33/320 • Number of events 38 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
7.9%
25/318 • Number of events 31 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
10.9%
35/320 • Number of events 39 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
10.4%
33/318 • Number of events 36 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Headache
|
11.2%
36/320 • Number of events 50 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
17.0%
54/318 • Number of events 67 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
19/320 • Number of events 29 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.1%
13/318 • Number of events 16 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
39.4%
126/320 • Number of events 160 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
32.7%
104/318 • Number of events 133 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
6.6%
21/320 • Number of events 23 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
21/318 • Number of events 25 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.1%
42/320 • Number of events 50 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
11.6%
37/318 • Number of events 42 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
10.6%
34/320 • Number of events 36 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
11.3%
36/318 • Number of events 37 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
40/320 • Number of events 57 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.5%
27/318 • Number of events 45 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.3%
65/320 • Number of events 81 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
15.4%
49/318 • Number of events 57 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.2%
23/320 • Number of events 23 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.4%
14/318 • Number of events 15 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.9%
54/320 • Number of events 61 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.5%
46/318 • Number of events 52 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.9%
102/320 • Number of events 131 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
25.2%
80/318 • Number of events 102 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
19/320 • Number of events 20 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.3%
17/318 • Number of events 19 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
17/320 • Number of events 18 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.3%
17/318 • Number of events 20 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.1%
122/320 • Number of events 124 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
35.2%
112/318 • Number of events 114 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.2%
23/320 • Number of events 23 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.5%
11/318 • Number of events 15 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.7%
15/320 • Number of events 18 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.7%
18/318 • Number of events 20 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.6%
21/320 • Number of events 25 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
5.0%
16/318 • Number of events 18 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.3%
49/320 • Number of events 55 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
13.2%
42/318 • Number of events 47 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
11.9%
38/320 • Number of events 45 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
10.1%
32/318 • Number of events 34 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
33/320 • Number of events 42 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.8%
28/318 • Number of events 29 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.6%
66/320 • Number of events 87 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
13.2%
42/318 • Number of events 59 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
20.0%
64/320 • Number of events 95 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
18.2%
58/318 • Number of events 98 • Up to approximately 38 months
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER