Trial Outcomes & Findings for Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study (NCT NCT04865289)
NCT ID: NCT04865289
Last Updated: 2025-12-02
Results Overview
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of pMMR participants was presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
Up to approximately 45 months
Results posted on
2025-12-02
Participant Flow
130 participants were enrolled in China. 66 participants were randomized in the global portion for MK-7902-001 (NCT03884101) and 64 in the China extension portion.
Participant milestones
| Measure |
Lenvatinib + Pembrolizumab
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
56
|
|
Overall Study
Treated
|
73
|
56
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
74
|
56
|
Reasons for withdrawal
| Measure |
Lenvatinib + Pembrolizumab
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Overall Study
Death
|
34
|
25
|
|
Overall Study
Physician Decision
|
27
|
27
|
|
Overall Study
Sponsor Decision
|
11
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
Baseline characteristics by cohort
| Measure |
Lenvatinib + Pembrolizumab
n=74 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 Years
STANDARD_DEVIATION 8.1 • n=9 Participants
|
58.3 Years
STANDARD_DEVIATION 7.3 • n=6 Participants
|
60.1 Years
STANDARD_DEVIATION 7.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=9 Participants
|
56 Participants
n=6 Participants
|
130 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=9 Participants
|
55 Participants
n=6 Participants
|
129 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
74 Participants
n=9 Participants
|
56 Participants
n=6 Participants
|
130 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 0
|
35 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
64 Participants
n=9 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG = 1
|
39 Participants
n=9 Participants
|
27 Participants
n=6 Participants
|
66 Participants
n=9 Participants
|
|
Prior Chemotherapy and/or Chemoradiation
Yes
|
21 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
39 Participants
n=9 Participants
|
|
Prior Chemotherapy and/or Chemoradiation
No
|
53 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
91 Participants
n=9 Participants
|
|
Mismatch Repair (MMR) Status
dMMR
|
17 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
29 Participants
n=9 Participants
|
|
Mismatch Repair (MMR) Status
pMMR
|
57 Participants
n=9 Participants
|
44 Participants
n=6 Participants
|
101 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 45 monthsPopulation: All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized.
PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of pMMR participants was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=57 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=44 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Progression-free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Mismatch Repair Proficient (pMMR) Participants
|
10.3 Months
Interval 6.4 to 12.7
|
10.2 Months
Interval 8.3 to 10.6
|
PRIMARY outcome
Timeframe: Up to approximately 45 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized.
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS of all randomized participants was presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=74 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
PFS Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants
|
11.7 Months
Interval 8.3 to 19.4
|
10.3 Months
Interval 8.3 to 12.5
|
PRIMARY outcome
Timeframe: Up to approximately 45 monthsPopulation: All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized.
OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for pMMR participants is presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=57 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=44 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Overall Survival (OS) in pMMR Participants
|
37.1 Months
Interval 19.5 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 21.7 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
PRIMARY outcome
Timeframe: Up to approximately 45 monthsPopulation: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion were analyzed according to the treatment arm to which they were randomized.
OS was measured from the time of randomization up to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all randomized participants is presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=74 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
OS in All Randomized Participants
|
NA Months
Interval 29.8 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
NA Months
Interval 25.1 to
NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
|
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Per the statistical analysis plan, all pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized.
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of pMMR participants who experienced a CR or PR is presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=55 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=44 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Objective Response Rate (ORR) Based on RECIST 1.1 as Assessed by BICR in pMMR Participants
|
50.9 Percentage of Participants
Interval 37.1 to 64.6
|
61.4 Percentage of Participants
Interval 45.5 to 75.6
|
SECONDARY outcome
Timeframe: Up to approximately 45 monthsPopulation: Per the statistical analysis plan, all Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion with measurable disease at the baseline scan were analyzed according to the treatment arm to which they were randomized.
ORR was defined as the percentage of participants who had a CR: Disappearance of all target lesions or a PR: At least a 30% decrease in the sum of diameters of target lesions as assessed using RECIST 1.1. The percentage of all randomized participants who experienced a CR or PR is presented.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=72 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
ORR Based on RECIST 1.1 as Assessed by BICR in All Randomized Participants
|
56.9 Percentage of Participants
Interval 44.7 to 68.6
|
66.1 Percentage of Participants
Interval 52.2 to 78.2
|
SECONDARY outcome
Timeframe: Baseline and up to approximately 18 weeksPopulation: All pMMR Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed.
The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=56 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=41 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Mean Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score in pMMR Participants
|
-7.00 Scores on a scale
Interval -12.49 to -1.51
|
-4.87 Scores on a scale
Interval -11.52 to 1.79
|
SECONDARY outcome
Timeframe: Baseline and up to approximately 18 weeksPopulation: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion who had at least one assessment available for EORTC QLQ-C30 and received at least one dose of the study intervention were analyzed.
The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=72 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=52 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Score in All Randomized Participants
|
-6.69 Scores on a scale
Interval -11.42 to -1.96
|
-5.96 Scores on a scale
Interval -11.65 to -0.26
|
SECONDARY outcome
Timeframe: From first dose date to 120 days after last dose date (up to approximately 58 months)Population: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=73 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
72 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: From first dose date to 120 days after last dose date (up to approximately 58 months)Population: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=73 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing a Serious Adverse Event (SAE)
|
40 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From first dose date to 120 days after last dose date (up to approximately 58 months)Population: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immune-related AEs (irAEs) were AEs that were considered immune-mediated or potentially immune-mediated and are well-documented for pembrolizumab. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. The number of participants with irAEs was reported for each arm.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=73 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Number of Participants Experiencing an Immune-related AE (irAE)
|
49 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From first dose date to last dose date (up to approximately 54 months)Population: All Chinese participants who were randomized to the global study (NCT03884101) and to the extension portion and received at least one dose of the study intervention were analyzed
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE was reported for each arm.
Outcome measures
| Measure |
Lenvatinib + Pembrolizumab
n=73 Participants
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 Participants
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Number of Participants Discontinuing From Study Treatment Due to an AE(s)
|
32 Participants
|
8 Participants
|
Adverse Events
Lenvatinib + Pembrolizumab
Serious events: 40 serious events
Other events: 72 other events
Deaths: 34 deaths
Paclitaxel + Carboplatin
Serious events: 17 serious events
Other events: 55 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Lenvatinib + Pembrolizumab
n=73 participants at risk
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 participants at risk
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Granulocytopenia
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Myelosuppression
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Thrombocytopenia
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Arrhythmia
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Arteriosclerosis coronary artery
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Myocardial injury
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Myocarditis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hypophysitis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Functional gastrointestinal disorder
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Haemorrhoids
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 acute
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 perforation
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hyperthermia malignant
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Pain
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Peripheral swelling
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Drug-induced liver injury
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 injury
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Infected cyst
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Spinal fracture
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Thoracic vertebral fracture
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 haemorrhage
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Electrocardiogram QT prolonged
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Protein urine present
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Cachexia
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Ketoacidosis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Bone pain
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Immune-mediated myositis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Intervertebral disc protrusion
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Sjogren's syndrome
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Epilepsy
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Neuralgia
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Subarachnoid haemorrhage
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Depression
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hydronephrosis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Pyelocaliectasis
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Renal impairment
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Dyspnoea
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Immune-mediated lung disease
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Pleural effusion
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Respiratory failure
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Upper-airway cough syndrome
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Dermatitis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Haemorrhage subcutaneous
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Aortic dissection
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Deep vein thrombosis
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
1.4%
1/73 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
n=73 participants at risk
Participants received lenvatinib daily and pembrolizumab once at the start of each 3-week treatment cycle.
|
Paclitaxel + Carboplatin
n=56 participants at risk
Participants received paclitaxel and carboplatin once at the start of each 3-week treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.8%
21/73 • Number of events 34 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
76.8%
43/56 • Number of events 107 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Leukopenia
|
2.7%
2/73 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
16.1%
9/56 • Number of events 49 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Neutropenia
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
16.1%
9/56 • Number of events 26 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Thrombocytopenia
|
6.8%
5/73 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
14.3%
8/56 • Number of events 12 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Palpitations
|
5.5%
4/73 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
60.3%
44/73 • Number of events 70 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
8.2%
6/73 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
16.4%
12/73 • Number of events 16 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 12 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
16.4%
12/73 • Number of events 13 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
17.9%
10/56 • Number of events 11 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
30.1%
22/73 • Number of events 72 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
4/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Dry mouth
|
8.2%
6/73 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Flatulence
|
6.8%
5/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
4/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Haematochezia
|
5.5%
4/73 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Mouth ulceration
|
6.8%
5/73 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
21.9%
16/73 • Number of events 22 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
39.3%
22/56 • Number of events 46 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 12 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
15.1%
11/73 • Number of events 20 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
30.4%
17/56 • Number of events 28 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Asthenia
|
9.6%
7/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Chest discomfort
|
5.5%
4/73 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
24.7%
18/73 • Number of events 21 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
14.3%
8/56 • Number of events 19 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
15.1%
11/73 • Number of events 13 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Pain
|
8.2%
6/73 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Peripheral swelling
|
6.8%
5/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
13.7%
10/73 • Number of events 14 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
2.7%
2/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
4/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
6.8%
5/73 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Periodontitis
|
8.2%
6/73 • Number of events 12 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
15.1%
11/73 • Number of events 13 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
30.1%
22/73 • Number of events 60 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.7%
6/56 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
42.5%
31/73 • Number of events 63 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
32.1%
18/56 • Number of events 31 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
11.0%
8/73 • Number of events 22 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
45.2%
33/73 • Number of events 55 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
13/56 • Number of events 27 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Bilirubin conjugated increased
|
6.8%
5/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 23 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
14.3%
8/56 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
15.1%
11/73 • Number of events 22 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 cholesterol increased
|
12.3%
9/73 • Number of events 35 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
4/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
19.2%
14/73 • Number of events 33 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 glucose increased
|
5.5%
4/73 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
4/56 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
19.2%
14/73 • Number of events 28 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
12.5%
7/56 • Number of events 10 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 pressure increased
|
8.2%
6/73 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
19.2%
14/73 • Number of events 29 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
9.6%
7/73 • Number of events 10 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
4/56 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hepatic enzyme increased
|
5.5%
4/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
30.1%
22/73 • Number of events 36 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
8.2%
6/73 • Number of events 10 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.7%
6/56 • Number of events 16 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
23.3%
17/73 • Number of events 44 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
64.3%
36/56 • Number of events 180 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
38.4%
28/73 • Number of events 58 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
50.0%
28/56 • Number of events 79 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Tri-iodothyronine decreased
|
6.8%
5/73 • Number of events 11 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Urinary occult blood positive
|
8.2%
6/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
30.1%
22/73 • Number of events 28 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
26.0%
19/73 • Number of events 55 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
66.1%
37/56 • Number of events 196 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
23.3%
17/73 • Number of events 22 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
12.5%
7/56 • Number of events 14 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hypercholesterolaemia
|
4.1%
3/73 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
23.3%
17/73 • Number of events 41 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hyperlipidaemia
|
12.3%
9/73 • Number of events 18 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.7%
6/56 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
17.8%
13/73 • Number of events 44 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hyperuricaemia
|
15.1%
11/73 • Number of events 20 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
17.8%
13/73 • Number of events 35 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
5.5%
4/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hypochloraemia
|
5.5%
4/73 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
24.7%
18/73 • Number of events 38 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
5.5%
4/73 • Number of events 11 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
15.1%
11/73 • Number of events 17 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
24.7%
18/73 • Number of events 23 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
16.1%
9/56 • Number of events 15 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
12.3%
9/73 • Number of events 9 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
20.5%
15/73 • Number of events 17 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
21.4%
12/56 • Number of events 19 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Anaesthesia
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.7%
6/56 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Dizziness
|
9.6%
7/73 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
1.8%
1/56 • Number of events 1 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
6.8%
5/73 • Number of events 8 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Hypoaesthesia
|
2.7%
2/73 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
46.4%
26/56 • Number of events 39 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Neuropathy peripheral
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
9.6%
7/73 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 7 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
20.5%
15/73 • Number of events 26 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
65.8%
48/73 • Number of events 127 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
8.9%
5/56 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
15.1%
11/73 • Number of events 14 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
16.4%
12/73 • Number of events 14 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
0/56 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Dyspnoea
|
0.00%
0/73 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 3 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
Alopecia
|
8.2%
6/73 • Number of events 6 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
80.4%
45/56 • Number of events 45 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
31.5%
23/73 • Number of events 31 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
6.8%
5/73 • Number of events 5 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
10.7%
6/56 • Number of events 11 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
5.5%
4/73 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
|
3.6%
2/56 • Number of events 2 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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
|
64.4%
47/73 • Number of events 120 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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%
3/56 • Number of events 4 • From randomization to the date of death or last participant data collection (up to approximately 61 months).
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 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 The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. 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