Trial Outcomes & Findings for A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (NCT NCT03948763)
NCT ID: NCT03948763
Last Updated: 2025-01-28
Results Overview
The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleeding 5) Any nonhematologic AE ≥ Grade 3 in severity, with some exceptions 6) Any Grade 3 or Grade 4 nonhematologic laboratory value that meets one of the study criteria 7) Febrile neutropenia Grade 3 or Grade 4 8) Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 9) Any treatment-related toxicity that causes participant to discontinue treatment during Cycle 1. 10) Grade 5 toxicity 11) Any other clinically significant toxicity judged to be a DLT by investigator.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
Cycle 1 (Up to 21 days)
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Part 1: V941 Monotherapy
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
15
|
20
|
16
|
16
|
|
Overall Study
Participants Switched Over From V941 Monotherapy to V941 + Pembrolizumab
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
15
|
20
|
16
|
16
|
Reasons for withdrawal
| Measure |
Part 1: V941 Monotherapy
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Overall Study
Sponsor's decision
|
0
|
2
|
6
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
2
|
12
|
13
|
10
|
11
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
4
|
Baseline Characteristics
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
Baseline characteristics by cohort
| Measure |
Part 1: V941 Monotherapy
n=3 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=15 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=20 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Age, Customized
>= 65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG = 0
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG = 1
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Primary Diagnosis
Adenocarcinoma of the Colon
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Primary Diagnosis
Adenocarcinoma of the Pancreas
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Primary Diagnosis
Carcinoma Of Ampulla of Vater
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Primary Diagnosis
Cholangiocarcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Primary Diagnosis
Colorectal Cancer, not otherwise specified
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Primary Diagnosis
Lung Cancer, not otherwise specified
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Primary Diagnosis
Pancreatic Cancer (Not Islets)
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Primary Diagnosis
Rectal
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Primary Diagnosis
Non-Small Cell Lung Cancer, not otherwise specified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Prior Line of Therapy
First Line
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Prior Line of Therapy
Second Line
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Prior Line of Therapy
Third Line
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Prior Line of Therapy
Fourth Line
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Prior Line of Therapy
Fifth Line or Greater
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 21 days)Population: The DLT evaluable population included all participants who received at least 1 dose of study treatment and were either observed for safety for 21 days after the first dose of treatment or experienced a DLT prior to 21 days after the first dose of treatment.
The following toxicities graded for severity using National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), were considered a DLT if judged by the investigator to be possibly related to study investigational products: 1) Grade 4 nonhematologic toxicity (ie. not a laboratory finding). 2) Grade 4 hematologic toxicity lasting ≥ 7 days, except thrombocytopenia: 3) Grade 4 thrombocytopenia of any duration 4) Grade 3 thrombocytopenia associated with clinically significant bleeding 5) Any nonhematologic AE ≥ Grade 3 in severity, with some exceptions 6) Any Grade 3 or Grade 4 nonhematologic laboratory value that meets one of the study criteria 7) Febrile neutropenia Grade 3 or Grade 4 8) Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity. 9) Any treatment-related toxicity that causes participant to discontinue treatment during Cycle 1. 10) Grade 5 toxicity 11) Any other clinically significant toxicity judged to be a DLT by investigator.
Outcome measures
| Measure |
Part 1: V941 Monotherapy
n=2 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=14 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 27 monthsPopulation: All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Part 1: V941 Monotherapy
n=3 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=20 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
3 Participants
|
15 Participants
|
20 Participants
|
16 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 monthsPopulation: All participants who received at least 1 dose of study treatment. For AEs which occurred during Part 1 prior to switch-over, the information is in the Part 1: V941 Monotherapy column. For AEs which occurred during Part 1 subsequent to switch-over, the information is in the Part 1: V941 + Pembrolizumab column.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinued study treatment due to an AE is reported.
Outcome measures
| Measure |
Part 1: V941 Monotherapy
n=3 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=20 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: All participants who received at least 1 dose of study treatment. Per protocol, the 1 participant who switched over from Arm 1 Part 1: V941 Monotherapy to Arm 2 Part 1: V941 + Pembrolizumab was excluded from Arm 2 Part 1: V941 + Pembrolizumab for this outcome measure.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by investigator is reported.
Outcome measures
| Measure |
Part 1: V941 Monotherapy
n=3 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=15 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=20 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=16 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0.0 Percentage of Participants
Interval 0.0 to 70.8
|
6.7 Percentage of Participants
Interval 0.2 to 31.9
|
5.0 Percentage of Participants
Interval 0.1 to 24.9
|
12.5 Percentage of Participants
Interval 1.6 to 38.3
|
0.0 Percentage of Participants
Interval 0.0 to 20.6
|
SECONDARY outcome
Timeframe: Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)Population: Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.
The presence of mutant KRAS specific T cells (G12D, G12V, G13D, G12C, and Wild type) in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The post-treatment ELISpot readout for a cycle is reported. A cycle is 3 weeks.
Outcome measures
| Measure |
Part 1: V941 Monotherapy
n=2 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=11 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=6 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=7 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=3 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12D Cycle 1
|
1.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.56 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.45
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12D Cycle 2
|
0.60 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.59 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.49
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12D Cycle 3
|
1.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.76 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.28
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12D Cycle 4
|
—
|
1.35 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.80
|
2.08 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.48
|
1.70 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.82
|
2.14 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.82
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12D Cycle 6
|
—
|
—
|
2.34 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.40
|
2.30 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.53
|
2.34 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.15
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12D Discontinuation Visit
|
0.54 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.34
|
—
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 1
|
—
|
0.59 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.53
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 2
|
0.90 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.12 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.27
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 1
|
1.08 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.24 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.54
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 3
|
—
|
0.88 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.54
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 4
|
—
|
1.84 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.14
|
2.04 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.17
|
1.94 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.67
|
2.25 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 6
|
—
|
—
|
1.64 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.43
|
1.77 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.21
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 7
|
—
|
2.20 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Cycle 9
|
—
|
2.20 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12V Discontinuation Visit
|
1.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.04
|
—
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12C Cycle 1
|
—
|
0.78 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.67
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12C Cycle 2
|
0.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.60 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.85
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12C Cycle 3
|
—
|
1.10 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.70
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12C Cycle 4
|
—
|
1.93 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.72
|
2.07 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.18
|
2.12 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.89
|
2.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12C Cycle 6
|
—
|
—
|
1.93 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.29
|
2.24 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.68
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G12C Discontinuation Visit
|
1.55 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G13D Cycle 1
|
—
|
0.65 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.49
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G13D Cycle 2
|
0.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.62 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.56
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G13D Cycle 3
|
—
|
0.91 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.87
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G13D Cycle 4
|
—
|
1.92 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.71
|
1.53 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.02
|
1.48 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.20
|
1.26 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G13D Cycle 6
|
—
|
—
|
1.60 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.12
|
1.75 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.05
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
KRAS G13D Discontinuation Visit
|
0.92 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.87
|
—
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 4
|
—
|
1.79 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.59
|
1.64 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.59
|
1.56 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.47
|
1.26 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.59
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 6
|
—
|
—
|
1.38 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.01
|
1.88 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.24
|
1.59 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.08
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 7
|
—
|
2.33 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 9
|
—
|
1.95 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Discontinuation Visit
|
0.80 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 2
|
0.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.49 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.60
|
—
|
—
|
—
|
|
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Wild Type Cycle 3
|
1.15 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.86 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.60
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)Population: Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.
Mean change from baseline in the quantity of mutant KRAS specific T cells in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The mean change is reported.
Outcome measures
| Measure |
Part 1: V941 Monotherapy
n=2 Participants
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=11 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=6 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=7 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=3 Participants
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12D Cycle 1
|
1.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.46 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.56
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12D Cycle 2
|
0.60 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.54 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.48
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12D Cycle 3
|
1.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.76 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.28
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12D Cycle 4
|
—
|
1.35 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.80
|
1.50 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.56
|
0.94 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.26
|
1.78 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.44
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12D Cycle 6
|
—
|
—
|
1.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.67
|
1.61 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.51
|
2.34 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.15
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12D Discontinuation Visit
|
-0.11 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 1
|
—
|
0.59 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.53
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 2
|
0.9 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.12 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.27
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 3
|
—
|
0.88 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.54
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 4
|
—
|
1.84 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.14
|
2.04 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.17
|
1.84 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.71
|
2.25 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 6
|
—
|
—
|
1.64 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.43
|
1.62 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.00
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 7
|
—
|
2.20 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Cycle 9
|
—
|
2.20 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12V Discontinuation Visit
|
1.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.04
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12C Cycle 1
|
—
|
0.78 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.67
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12C Cycle 2
|
0.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.60 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.85
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12C Cycle 3
|
—
|
1.10 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.70
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12C Cycle 4
|
—
|
1.93 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.72
|
1.64 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.26
|
1.68 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.91
|
1.85 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12C Cycle 6
|
—
|
—
|
1.10 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.07
|
1.75 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.95
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G12C Discontinuation Visit
|
1.55 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G13D Cycle 1
|
—
|
0.26 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G13D Cycle 2
|
-0.3 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.62 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.56
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G13D Cycle 3
|
—
|
0.41 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.70
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G13D Cycle 4
|
—
|
1.92 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.71
|
1.28 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.76
|
0.25 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.22
|
1.26 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G13D Cycle 6
|
—
|
—
|
1.06 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.73
|
0.55 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.05
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
KRAS G13D Discontinuation Visit
|
0.77 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 1.08
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 1
|
1.08 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
-0.23 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.67
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 2
|
0.00 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.28 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.59
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 3
|
1.15 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
0.45 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.90
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 4
|
—
|
1.79 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.59
|
1.32 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.54
|
0.79 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.90
|
0.76 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.66
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 6
|
—
|
—
|
0.90 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.63
|
1.12 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.54
|
0.99 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.08
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 7
|
—
|
2.33 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Cycle 9
|
—
|
1.95 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation NA
Standard deviation was not calculatable when n\<2.
|
—
|
—
|
—
|
|
Mean Change From Baseline in Quantity of Mutant KRAS Specific T Cells
Wild Type Discontinuation Visit
|
0.80 Log10(IFN-g (SFC per 10^6 PBMC))
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 24 monthsPopulation: Data were not collected for this outcome measure.
TCR clonality and diversity in the periphery and tumor.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: V941 Monotherapy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1: V941 + Pembrolizumab
Serious events: 6 serious events
Other events: 15 other events
Deaths: 12 deaths
Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
Serious events: 5 serious events
Other events: 20 other events
Deaths: 13 deaths
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
Serious events: 7 serious events
Other events: 16 other events
Deaths: 12 deaths
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
Serious events: 9 serious events
Other events: 15 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Part 1: V941 Monotherapy
n=3 participants at risk
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=15 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy)
n=1 participants at risk
Participants who received the initial treatment of V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and developed progressive disease were eligible to switch over to V941 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles.
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=20 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=16 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=16 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Death
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
Other adverse events
| Measure |
Part 1: V941 Monotherapy
n=3 participants at risk
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
|
Part 1: V941 + Pembrolizumab
n=15 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
|
Part 1: V941 + Pembrolizumab (Switched Over From V941 Monotherapy)
n=1 participants at risk
Participants who received the initial treatment of V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and developed progressive disease were eligible to switch over to V941 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles.
|
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
n=20 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
n=16 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
n=16 participants at risk
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
|
|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.0%
4/16 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.0%
4/16 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.0%
4/16 • Number of events 5 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
3/15 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.0%
4/16 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
3/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
37.5%
6/16 • Number of events 16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
4/20 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
50.0%
8/16 • Number of events 8 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Infusion site bruising
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Injection site discomfort
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Injection site pain
|
66.7%
2/3 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
3/15 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
65.0%
13/20 • Number of events 32 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
62.5%
10/16 • Number of events 22 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
50.0%
8/16 • Number of events 8 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.0%
4/16 • Number of events 17 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
25.0%
4/16 • Number of events 5 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Injection site urticaria
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 6 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
65.0%
13/20 • Number of events 24 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
62.5%
10/16 • Number of events 35 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
62.5%
10/16 • Number of events 11 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
General disorders
Vaccination site pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
26.7%
4/15 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
3/15 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 6 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
3/15 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Aura
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
3/15 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 6 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
15.0%
3/20 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
18.8%
3/16 • Number of events 3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
20.0%
4/20 • Number of events 4 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
12.5%
2/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 6 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord atrophy
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
13.3%
2/15 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.7%
1/15 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/20 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
10.0%
2/20 • Number of events 2 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/15 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
5.0%
1/20 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
0.00%
0/16 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
6.2%
1/16 • Number of events 1 • Up to approximately 27 months
All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. MedDRA preferred terms "Neoplasm Progression", "Malignant Neoplasm Progression" and "Disease Progression" not related to the drug are excluded.
|
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 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