Trial Outcomes & Findings for Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012) (NCT NCT04246177)
NCT ID: NCT04246177
Last Updated: 2026-09-03
Results Overview
PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
480 participants
Primary outcome timeframe
Up to approximately 43.5 Months
Results posted on
2026-09-03
Participant Flow
480 participants were enrolled. Of the 480 enrolled participants 1 participant was enrolled in the study in error and did not receive study treatment and 1 participant withdrew from the study and subsequently died without receiving study treatment.
Participant milestones
| Measure |
Lenvatinib Plus Pembrolizumab Plus TACE
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Oral Placebo Plus IV Placebo Plus TACE
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Overall Study
STARTED
|
237
|
243
|
|
Overall Study
Treated
|
237
|
241
|
|
Overall Study
Participants Ongoing
|
105
|
114
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
237
|
243
|
Reasons for withdrawal
| Measure |
Lenvatinib Plus Pembrolizumab Plus TACE
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Oral Placebo Plus IV Placebo Plus TACE
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Overall Study
Death
|
124
|
122
|
|
Overall Study
Randomized By Mistake Without Study Treatment
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Participants Ongoing
|
105
|
114
|
Baseline Characteristics
Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)
Baseline characteristics by cohort
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 10.7 • n=136 Participants
|
65.2 Years
STANDARD_DEVIATION 10.4 • n=136 Participants
|
64.5 Years
STANDARD_DEVIATION 10.6 • n=272 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=136 Participants
|
37 Participants
n=136 Participants
|
82 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=136 Participants
|
206 Participants
n=136 Participants
|
398 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=136 Participants
|
33 Participants
n=136 Participants
|
64 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=136 Participants
|
199 Participants
n=136 Participants
|
392 Participants
n=272 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=136 Participants
|
11 Participants
n=136 Participants
|
24 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
168 Participants
n=136 Participants
|
179 Participants
n=136 Participants
|
347 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=136 Participants
|
47 Participants
n=136 Participants
|
98 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=136 Participants
|
7 Participants
n=136 Participants
|
14 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=136 Participants
|
6 Participants
n=136 Participants
|
12 Participants
n=272 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
ECOG= 0
|
216 Participants
n=136 Participants
|
213 Participants
n=136 Participants
|
429 Participants
n=272 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
ECOG= 1
|
21 Participants
n=136 Participants
|
30 Participants
n=136 Participants
|
51 Participants
n=272 Participants
|
|
Geographic Region
Asia without Japan
|
135 Participants
n=136 Participants
|
137 Participants
n=136 Participants
|
272 Participants
n=272 Participants
|
|
Geographic Region
Non-Asia with Japan
|
102 Participants
n=136 Participants
|
106 Participants
n=136 Participants
|
208 Participants
n=272 Participants
|
|
Serum Albumin (ALBI) Grade
Grade 1
|
171 Participants
n=136 Participants
|
174 Participants
n=136 Participants
|
345 Participants
n=272 Participants
|
|
Serum Albumin (ALBI) Grade
Grade 2
|
65 Participants
n=136 Participants
|
69 Participants
n=136 Participants
|
134 Participants
n=272 Participants
|
|
Serum Albumin (ALBI) Grade
Missing
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
|
Tumor Burden Stratum per Investigator
≤ 6
|
112 Participants
n=136 Participants
|
116 Participants
n=136 Participants
|
228 Participants
n=272 Participants
|
|
Tumor Burden Stratum per Investigator
> 6 and ≤ 12
|
120 Participants
n=136 Participants
|
117 Participants
n=136 Participants
|
237 Participants
n=272 Participants
|
|
Tumor Burden Stratum per Investigator
> 12
|
5 Participants
n=136 Participants
|
10 Participants
n=136 Participants
|
15 Participants
n=272 Participants
|
|
Alpha Fetoprotein at Screening Lab
> 400 ng/mL
|
37 Participants
n=136 Participants
|
40 Participants
n=136 Participants
|
77 Participants
n=272 Participants
|
|
Alpha Fetoprotein at Screening Lab
≤ 400 ng/mL
|
200 Participants
n=136 Participants
|
203 Participants
n=136 Participants
|
403 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 43.5 MonthsPopulation: All randomized participants.
PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
|
14.6 Months
Interval 12.6 to 16.7
|
10.0 Months
Interval 8.1 to 12.2
|
PRIMARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
OS was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Overall Survival (OS)
|
40.4 Months
Interval 34.4 to 47.0
|
40.8 Months
Interval 35.2 to 45.8
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for hepatocellular carcinoma (HCC) allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable target lesions, taking as reference the smallest SODs of viable target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
PFS Per Modified RECIST (mRECIST) as Assessed by BICR
|
14.6 Months
Interval 12.5 to 17.6
|
9.8 Months
Interval 8.1 to 11.1
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
ORR was defined as the percentage of participants who achieve a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Objective Response Rate (ORR) Per mRECIST as Assessed by BICR
|
71.3 Percentage of Participants
Interval 65.1 to 77.0
|
49.4 Percentage of Participants
Interval 42.9 to 55.8
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
DCR was defined as the percentage of participants who have achieved a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Disease Control Rate (DCR) Per mRECIST as Assessed by BICR
|
90.3 Percentage of Participants
Interval 85.8 to 93.7
|
81.9 Percentage of Participants
Interval 76.5 to 86.5
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: The analysis population consisted of all randomized participants and had a documented confirmed response (complete response \[CR\] or partial response \[PR\]) per mRECIST as assessed by BICR.
For participants who demonstrated confirmed CR or PR per mRECIST assessed by BICR, DOR was defined as the time from the first documented evidence of a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable \[contrast enhancement in the arterial phase\] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=169 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=120 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Duration of Response (DOR) Per mRECIST as Assessed by BICR
|
14.5 Months
Interval 12.5 to 16.6
|
12.5 Months
Interval 10.4 to 14.7
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. TTP per mRECIST as assessed by BICR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Time-To-Progression (TTP) Per mRECIST as Assessed by BICR
|
16.6 Months
Interval 14.5 to 18.9
|
10.2 Months
Interval 8.2 to 12.3
|
SECONDARY outcome
Timeframe: Up to approximately 71.1 MonthsAn AE will be 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 71.1 MonthsAn AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 71.1 MonthsAn AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event was considered not due to disease progression as judged by the investigator: among participants with Baseline ALT \<2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT \>3 × the Baseline level; ALT \>500 U/L regardless of baseline level; total bilirubin \>3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for \>3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE of clinical interest was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 71.1 MonthsAn AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
ORR Per RECIST 1.1 as Assessed by BICR
|
48.1 Percentage of Participants
Interval 41.6 to 54.7
|
33.7 Percentage of Participants
Interval 27.8 to 40.1
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
DCR Per RECIST 1.1 as Assessed by BICR
|
89.9 Percentage of participants
Interval 85.3 to 93.4
|
81.1 Percentage of participants
Interval 75.6 to 85.8
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: The analysis population consisted of all randomized participants and had a documented confirmed response (complete response \[CR\] or partial response \[PR\]) per mRECIST as assessed by BICR.
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=114 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=82 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
DOR Per RECIST 1.1 as Assessed by BICR
|
14.3 Months
Interval 12.1 to 16.6
|
12.6 Months
Interval 9.8 to 16.9
|
SECONDARY outcome
Timeframe: Up to approximately 61.7 MonthsPopulation: All randomized participants.
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 Participants
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=243 Participants
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
TTP Per RECIST 1.1 as Assessed by BICR
|
16.6 Months
Interval 14.6 to 18.5
|
10.4 Months
Interval 8.2 to 12.5
|
Adverse Events
Lenvatinib + Pembrolizumab + TACE
Serious events: 122 serious events
Other events: 234 other events
Deaths: 126 deaths
Placebo + TACE
Serious events: 62 serious events
Other events: 229 other events
Deaths: 127 deaths
Serious adverse events
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 participants at risk
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=241 participants at risk
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
4/237 • Number of events 4 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Angina unstable
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Bradycardia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Pericardial effusion
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Pericarditis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Anal fistula
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Anorectal varices haemorrhage
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Ascites
|
3.0%
7/237 • Number of events 7 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.42%
1/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
8/237 • Number of events 8 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
4/237 • Number of events 4 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
2.1%
5/237 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.2%
3/241 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.84%
2/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Death
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
General physical health deterioration
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Oedema peripheral
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Strangulated hernia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.7%
4/237 • Number of events 4 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Anal abscess
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Bronchitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Cellulitis
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Escherichia infection
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Gingivitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Infection
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Infectious pleural effusion
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Liver abscess
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.5%
6/241 • Number of events 6 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Osteomyelitis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia
|
1.7%
4/237 • Number of events 4 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Sepsis
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.7%
4/241 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Septic shock
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Skin infection
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Soft tissue infection
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Drain site complication
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Post embolisation syndrome
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Amylase increased
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood bilirubin increased
|
3.4%
8/237 • Number of events 10 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Lipase increased
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Neutrophil count decreased
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Platelet count decreased
|
1.3%
3/237 • Number of events 4 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.1%
5/241 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Transaminases increased
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
White blood cell count decreased
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
3/237 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.2%
3/241 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hepatogenous diabetes
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Altered state of consciousness
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Cerebral infarction
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Hepatic encephalopathy
|
5.1%
12/237 • Number of events 18 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.83%
2/241 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Lacunar infarction
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Loss of consciousness
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Product Issues
Device leakage
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Product Issues
Device malfunction
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
4/237 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Nephritis
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
3/237 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypertension
|
0.84%
2/237 • Number of events 2 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypovolaemic shock
|
0.42%
1/237 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/237 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.41%
1/241 • Number of events 1 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
Other adverse events
| Measure |
Lenvatinib + Pembrolizumab + TACE
n=237 participants at risk
Participants received a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib was administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years \[\~35 cycles\] or longer with Sponsor approval). Pembrolizumab was administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
Placebo + TACE
n=241 participants at risk
Participants received a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo were administered once a day during each 21-day cycle for up to 2 years (\~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (\~17 doses). Participants underwent TACE as a background procedure of chemotherapeutic and embolic agent(s).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.1%
50/237 • Number of events 93 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
18.7%
45/241 • Number of events 65 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Hyperthyroidism
|
7.2%
17/237 • Number of events 17 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.7%
4/241 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
35.4%
84/237 • Number of events 108 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.3%
20/241 • Number of events 22 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.6%
18/237 • Number of events 22 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
5.0%
12/241 • Number of events 13 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.7%
61/237 • Number of events 94 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
23.2%
56/241 • Number of events 87 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.5%
25/237 • Number of events 29 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.4%
25/241 • Number of events 33 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Ascites
|
8.0%
19/237 • Number of events 24 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.5%
6/241 • Number of events 7 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Constipation
|
20.3%
48/237 • Number of events 60 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.3%
49/241 • Number of events 67 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.1%
76/237 • Number of events 133 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
9.1%
22/241 • Number of events 24 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
12/237 • Number of events 14 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
4.1%
10/241 • Number of events 10 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.5%
13/237 • Number of events 14 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.1%
5/241 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
20.7%
49/237 • Number of events 60 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
15.4%
37/241 • Number of events 48 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
7.6%
18/237 • Number of events 18 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
0.00%
0/241 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
13.1%
31/237 • Number of events 37 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.0%
24/241 • Number of events 26 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
28.7%
68/237 • Number of events 86 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
14.9%
36/241 • Number of events 43 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Malaise
|
8.4%
20/237 • Number of events 24 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.5%
6/241 • Number of events 6 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Oedema peripheral
|
11.0%
26/237 • Number of events 31 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
4.1%
10/241 • Number of events 10 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
23.2%
55/237 • Number of events 76 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
23.2%
56/241 • Number of events 75 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.2%
17/237 • Number of events 27 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.3%
8/241 • Number of events 8 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Hepatic pain
|
5.9%
14/237 • Number of events 19 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
6.6%
16/241 • Number of events 23 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
21.1%
50/237 • Number of events 57 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
14.5%
35/241 • Number of events 35 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia
|
5.1%
12/237 • Number of events 12 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.1%
5/241 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
20/237 • Number of events 21 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.7%
9/241 • Number of events 13 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
25/237 • Number of events 41 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.3%
8/241 • Number of events 11 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Post embolisation syndrome
|
21.9%
52/237 • Number of events 84 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
27.4%
66/241 • Number of events 111 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
39.7%
94/237 • Number of events 162 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
32.8%
79/241 • Number of events 120 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Amylase increased
|
13.5%
32/237 • Number of events 57 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
11.6%
28/241 • Number of events 55 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
38.8%
92/237 • Number of events 202 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
32.0%
77/241 • Number of events 125 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.5%
25/237 • Number of events 37 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.4%
25/241 • Number of events 33 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood bilirubin increased
|
35.4%
84/237 • Number of events 185 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
23.2%
56/241 • Number of events 109 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood creatinine increased
|
7.6%
18/237 • Number of events 23 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.3%
8/241 • Number of events 12 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.8%
28/237 • Number of events 51 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
7.5%
18/241 • Number of events 22 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
12.7%
30/237 • Number of events 42 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
4.6%
11/241 • Number of events 13 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
C-reactive protein increased
|
6.8%
16/237 • Number of events 30 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
4.6%
11/241 • Number of events 13 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
22.8%
54/237 • Number of events 76 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
12.4%
30/241 • Number of events 45 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Lipase increased
|
13.5%
32/237 • Number of events 61 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
12.9%
31/241 • Number of events 50 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Lymphocyte count decreased
|
8.9%
21/237 • Number of events 41 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.3%
20/241 • Number of events 39 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Neutrophil count decreased
|
20.7%
49/237 • Number of events 126 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
9.5%
23/241 • Number of events 55 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Neutrophil count increased
|
3.4%
8/237 • Number of events 9 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
5.4%
13/241 • Number of events 20 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Platelet count decreased
|
40.5%
96/237 • Number of events 228 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
26.1%
63/241 • Number of events 134 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
SARS-CoV-2 test positive
|
5.1%
12/237 • Number of events 12 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.2%
3/241 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Weight decreased
|
38.4%
91/237 • Number of events 117 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
7.1%
17/241 • Number of events 24 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Investigations
White blood cell count decreased
|
22.4%
53/237 • Number of events 144 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
14.9%
36/241 • Number of events 88 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.0%
83/237 • Number of events 98 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
12.9%
31/241 • Number of events 37 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
16/237 • Number of events 25 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
5.8%
14/241 • Number of events 19 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
12/237 • Number of events 19 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.2%
3/241 • Number of events 3 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.9%
14/237 • Number of events 19 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
5.4%
13/241 • Number of events 20 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.3%
60/237 • Number of events 113 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
20.3%
49/241 • Number of events 81 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.2%
36/237 • Number of events 65 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
12.9%
31/241 • Number of events 53 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.6%
18/237 • Number of events 25 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
6.2%
15/241 • Number of events 30 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.5%
13/237 • Number of events 23 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.3%
8/241 • Number of events 10 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
36/237 • Number of events 44 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.0%
24/241 • Number of events 26 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
19/237 • Number of events 21 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.3%
20/241 • Number of events 21 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
15/237 • Number of events 16 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.5%
6/241 • Number of events 6 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Headache
|
7.6%
18/237 • Number of events 20 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
6.6%
16/241 • Number of events 17 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Insomnia
|
6.8%
16/237 • Number of events 18 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
9.1%
22/241 • Number of events 27 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Haematuria
|
7.2%
17/237 • Number of events 30 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
4.6%
11/241 • Number of events 15 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
44.3%
105/237 • Number of events 215 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
11.2%
27/241 • Number of events 45 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
22/237 • Number of events 25 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
6.2%
15/241 • Number of events 15 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
23.2%
55/237 • Number of events 67 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.1%
5/241 • Number of events 5 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
26.2%
62/237 • Number of events 70 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
2.1%
5/241 • Number of events 6 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.1%
31/237 • Number of events 35 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.3%
20/241 • Number of events 21 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.8%
35/237 • Number of events 45 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.7%
4/241 • Number of events 4 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypertension
|
53.2%
126/237 • Number of events 217 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
22.0%
53/241 • Number of events 75 • Up to approximately 61.7 Months
All-Cause Mortality includes all allocated participants. Serious and Other AEs include all allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER