Trial Outcomes & Findings for Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (NCT NCT04303169)
NCT ID: NCT04303169
Last Updated: 2026-08-27
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
146 participants
Primary outcome timeframe
Up to approximately 17 months
Results posted on
2026-08-27
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Vibostolimab
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
15
|
25
|
27
|
26
|
|
Overall Study
Treated
|
26
|
25
|
15
|
25
|
26
|
26
|
|
Overall Study
Participants Who Received Surgery
|
25
|
23
|
14
|
22
|
25
|
23
|
|
Overall Study
Participants Who Received Adjuvant Treatment
|
20
|
19
|
11
|
17
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
19
|
12
|
20
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
3
|
5
|
5
|
4
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Vibostolimab
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
4
|
2
|
4
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
2
|
0
|
|
Overall Study
Randomized by Mistake Without Receiving Study Intervention
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=27 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=27 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
17 Participants
n=31 Participants
|
15 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
15 Participants
n=29 Participants
|
19 Participants
n=106 Participants
|
14 Participants
n=6 Participants
|
88 Participants
n=6 Participants
|
|
Age, Continuous
|
58.2 Years
STANDARD_DEVIATION 13.1 • n=31 Participants
|
59.4 Years
STANDARD_DEVIATION 13.1 • n=49 Participants
|
63.8 Years
STANDARD_DEVIATION 11.8 • n=80 Participants
|
60.7 Years
STANDARD_DEVIATION 15.6 • n=29 Participants
|
62.1 Years
STANDARD_DEVIATION 12.3 • n=106 Participants
|
61.5 Years
STANDARD_DEVIATION 14.2 • n=6 Participants
|
60.8 Years
STANDARD_DEVIATION 13.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=31 Participants
|
12 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
10 Participants
n=29 Participants
|
8 Participants
n=106 Participants
|
12 Participants
n=6 Participants
|
58 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=31 Participants
|
23 Participants
n=49 Participants
|
13 Participants
n=80 Participants
|
23 Participants
n=29 Participants
|
21 Participants
n=106 Participants
|
24 Participants
n=6 Participants
|
127 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=31 Participants
|
24 Participants
n=49 Participants
|
14 Participants
n=80 Participants
|
25 Participants
n=29 Participants
|
27 Participants
n=106 Participants
|
26 Participants
n=6 Participants
|
139 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 17 monthsPopulation: All randomized participants who received ≥1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced an Adverse Event (AE)
|
96.2 Percentage of participants
|
96.0 Percentage of participants
|
93.3 Percentage of participants
|
92.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 13 monthsPopulation: All randomized participants who received ≥1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Intervention Due to an AE
|
11.5 Percentage of participants
|
28.0 Percentage of participants
|
0.0 Percentage of participants
|
8.0 Percentage of participants
|
26.9 Percentage of participants
|
19.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All randomized participants who received ≥1 dose of study intervention.
pCR rate was defined as the percentage of participants with complete absence of viable tumor in the treated tumor bed as assessed by central review of the pathology results. Per protocol, pCR rate with 90% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Pathological Complete Response (pCR) Rate With 90% Confidence Interval (CI)
|
38.5 Percentage of Participants
Interval 22.6 to 56.4
|
28.0 Percentage of Participants
Interval 13.9 to 46.2
|
40.0 Percentage of Participants
Interval 19.1 to 64.0
|
28.0 Percentage of Participants
Interval 13.9 to 46.2
|
38.5 Percentage of Participants
Interval 22.6 to 56.4
|
42.3 Percentage of Participants
Interval 25.8 to 60.2
|
PRIMARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All randomized participants who received ≥1 dose of study intervention.
pCR rate was defined as the percentage of participants with complete absence of viable tumor in the treated tumor bed as assessed by central review of the pathology results. Per protocol, pCR rate with 95% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
pCR Rate With 95% CI
|
38.5 Percentage of Participants
Interval 20.2 to 59.4
|
28.0 Percentage of Participants
Interval 12.1 to 49.4
|
40.0 Percentage of Participants
Interval 16.3 to 67.7
|
28.0 Percentage of Participants
Interval 12.1 to 49.4
|
38.5 Percentage of Participants
Interval 20.2 to 59.4
|
42.3 Percentage of Participants
Interval 23.4 to 63.1
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All randomized participants who received ≥1 dose of study intervention.
Near pCR was defined as the percentage of participants with \>0% but ≤10% of viable tumor cells in the treated tumor bed as assessed by central review of the pathology results. Per protocol, near pCR rate with 90% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Near pCR Rate With 90% CI
|
11.5 Percentage of Participants
Interval 3.2 to 27.2
|
12.0 Percentage of Participants
Interval 3.4 to 28.2
|
6.7 Percentage of Participants
Interval 0.3 to 27.9
|
4.0 Percentage of Participants
Interval 0.2 to 17.6
|
19.2 Percentage of Participants
Interval 7.9 to 36.3
|
0.0 Percentage of Participants
Interval 0.0 to 10.9
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All randomized participants who received ≥1 dose of study intervention.
Near pCR was defined as the percentage of participants with \>0% but ≤10% of viable tumor cells in the treated tumor bed as assessed by central review of the pathology results. Per protocol, near pCR rate with 95% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Near pCR Rate With 95% CI
|
11.5 Percentage of Participants
Interval 2.4 to 30.2
|
12.0 Percentage of Participants
Interval 2.5 to 31.2
|
6.7 Percentage of Participants
Interval 0.2 to 31.9
|
4.0 Percentage of Participants
Interval 0.1 to 20.4
|
19.2 Percentage of Participants
Interval 6.6 to 39.4
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All randomized participants who received ≥1 dose of study intervention.
pPR rate was defined as the percentage of participants with \>10% but ≤50% of the treated tumor bed occupied by viable tumor cells as assessed by central review of the pathology results. Per protocol, pPR rate with 90% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Pathological Partial Response (pPR) Rate With 90% CI
|
30.8 Percentage of Participants
Interval 16.3 to 48.7
|
12.0 Percentage of Participants
Interval 3.4 to 28.2
|
26.7 Percentage of Participants
Interval 9.7 to 51.1
|
8.0 Percentage of Participants
Interval 1.4 to 23.1
|
19.2 Percentage of Participants
Interval 7.9 to 36.3
|
7.7 Percentage of Participants
Interval 1.4 to 22.3
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All randomized participants who received ≥1 dose of study intervention.
pPR rate was defined as the percentage of participants with \>10% but ≤50% of the treated tumor bed occupied by viable tumor cells as assessed by central review of the pathology results. Per protocol, pPR rate with 95% CI was reported.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
pPR Rate With 95% CI
|
30.8 Percentage of Participants
Interval 14.3 to 51.8
|
12.0 Percentage of Participants
Interval 2.5 to 31.2
|
26.7 Percentage of Participants
Interval 7.8 to 55.1
|
8.0 Percentage of Participants
Interval 1.0 to 26.0
|
19.2 Percentage of Participants
Interval 6.6 to 39.4
|
7.7 Percentage of Participants
Interval 0.9 to 25.1
|
SECONDARY outcome
Timeframe: Up to approximately 62 monthsPopulation: All randomized participants who received neoadjuvant treatment and underwent surgery to completely resect the tumors.
RFS was defined as the time from the date of surgery to (1) any recurrence (local, regional, or distant) per RECIST 1.1 as assessed by the investigator or (2) death due to any cause (both cancer and noncancer causes of death). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, RFS per RECIST 1.1 as assessed by the investigator was presented.
Outcome measures
| Measure |
Pembrolizumab + Vibostolimab
n=23 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=22 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=14 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=21 Participants
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=24 Participants
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=23 Participants
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Recurrence-Free Survival (RFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by The Investigator
|
NA Months
NA = Median, lower limit, and upper limit of 95% CI were not reached due to insufficient number of participants with an event
|
NA Months
NA = Median, lower limit, and upper limit of 95% CI were not reached due to insufficient number of participants with an event
|
NA Months
Interval 17.6 to
NA = Median and upper limit of 95% CI were not reached due to insufficient number of participants with an event
|
NA Months
NA = Median, lower limit, and upper limit of 95% CI were not reached due to insufficient number of participants with an event
|
NA Months
NA = Median, lower limit, and upper limit of 95% CI were not reached due to insufficient number of participants with an event
|
NA Months
NA = Median, lower limit, and upper limit of 95% CI were not reached due to insufficient number of participants with an event
|
Adverse Events
Pembrolizumab + Vibostolimab
Serious events: 3 serious events
Other events: 25 other events
Deaths: 4 deaths
Pembrolizumab + Gebasaxturev
Serious events: 6 serious events
Other events: 24 other events
Deaths: 4 deaths
Pembrolizumab
Serious events: 3 serious events
Other events: 14 other events
Deaths: 2 deaths
Pembrolizumab + MK-4830
Serious events: 10 serious events
Other events: 23 other events
Deaths: 4 deaths
Favezelimab (+) Pembrolizumab
Serious events: 9 serious events
Other events: 23 other events
Deaths: 1 deaths
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
Serious events: 9 serious events
Other events: 25 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Pembrolizumab + Vibostolimab
n=26 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 participants at risk
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Localised infection
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Meningitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Wound infection
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage 0
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Haematoma
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab + Vibostolimab
n=26 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus vibostolimab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + Gebasaxturev
n=25 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus gebasaxturev 3 × 10\^8 tissue culture infectious dose 50%/mL (TCID50) administered intratumorally on Days 1, 3, 5, 8, and 22 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab
n=15 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + MK-4830
n=25 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, plus MK-4830 800 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Favezelimab (+) Pembrolizumab
n=26 participants at risk
Neoadjuvant treatment: Participants received a coformulation of favezelimab 800 mg (+) pembrolizumab 200 mg by IV infusion administered on Day 1 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
Pembrolizumab + All-Trans Retinoic Acid (ATRA)
n=26 participants at risk
Neoadjuvant treatment: Participants received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 1 cycle, plus ATRA 75 mg/m\^2 orally twice a day (bid) on Days 1, 2, and 3 of a 21-day cycle for 2 cycles, prior to surgery.
Adjuvant treatment: Following surgery, participants who were disease free with tumor negative margins, as assessed by the investigator, received pembrolizumab 400 mg by IV infusion administered on Day 1 of a 42-day cycle for 8 cycles.
A subset of participants who had confirmed radiographic disease progression with unresectable tumor, unacceptable toxicity, a confirmed positive pregnancy test, withdrawal of consent, or distant metastasis did not receive surgery or adjuvant treatment.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Ear and labyrinth disorders
Exostosis of external ear canal
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
4/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
5/25 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
24.0%
6/25 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
23.1%
6/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
4/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
24.0%
6/25 • Number of events 8 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
28.0%
7/25 • Number of events 8 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
30.8%
8/26 • Number of events 10 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
26.9%
7/26 • Number of events 10 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
15.4%
4/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
38.5%
10/26 • Number of events 12 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
38.5%
10/26 • Number of events 15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Asthenia
|
7.7%
2/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
28.0%
7/25 • Number of events 7 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
3/15 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Axillary pain
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Chills
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Fatigue
|
38.5%
10/26 • Number of events 15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
32.0%
8/25 • Number of events 10 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
3/15 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
5/25 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
34.6%
9/26 • Number of events 9 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
23.1%
6/26 • Number of events 7 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
15.4%
4/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Injection site pain
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
5/25 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Oedema peripheral
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pyrexia
|
15.4%
4/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
COVID-19
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
5/25 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Infected bite
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Rhinitis
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Wound infection
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Incision site hypoaesthesia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
19.2%
5/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
23.1%
6/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Seroma
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
4/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Amylase increased
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
11.5%
3/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
15.4%
4/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
20.0%
3/15 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood potassium increased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Lipase increased
|
15.4%
4/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Weight decreased
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.6%
9/26 • Number of events 9 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
33.3%
5/15 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
19.2%
5/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
19.2%
5/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Headache
|
34.6%
9/26 • Number of events 10 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
26.9%
7/26 • Number of events 7 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
76.9%
20/26 • Number of events 31 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
2/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Pollakiuria
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
6/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
23.1%
6/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
15.4%
4/26 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
8.0%
2/25 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
15.4%
4/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
13/26 • Number of events 15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
40.0%
10/25 • Number of events 10 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
33.3%
5/15 • Number of events 7 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
15.4%
4/26 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
34.6%
9/26 • Number of events 9 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
6/26 • Number of events 7 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
26.9%
7/26 • Number of events 9 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
26.9%
7/26 • Number of events 7 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.8%
1/26 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.5%
3/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
2/26 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
30.8%
8/26 • Number of events 8 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
24.0%
6/25 • Number of events 6 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
13.3%
2/15 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
12.0%
3/25 • Number of events 3 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Hypotension
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
4.0%
1/25 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/15 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
26.7%
4/15 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
16.0%
4/25 • Number of events 4 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
19.2%
5/26 • Number of events 5 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
2/26 • Number of events 2 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
6.7%
1/15 • Number of events 1 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/25 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/26 • Up to approximately 62 months
All-Cause Mortality was reported for all randomized participants. Serious and nonserious AEs were reported for all randomized participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression," "Malignant neoplasm progression," and "Disease progression" not related to study drug were 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 The results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. 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.
- Publication restrictions are in place
Restriction type: OTHER